We are seeking a Senior Validation Specialist to lead validation activities at our client’s pharmaceutical manufacturing facility in Indianapolis, IN. The role is responsible for ensuring that facilities, utilities, equipment, computerized systems, and manufacturing processes remain in a validated, inspection‑ready state in accordance with FDA, EU GMP, and internal quality standards. The Senior Validation Specialist will act as a subject matter expert (SME), partnering closely with Engineering, Quality, Manufacturing, and IT to plan, execute, and continuously improve the site’s validation program.

Key Responsibilities:

• Lead the development, execution, and maintenance of validation lifecycle documentation, including Validation Master Plan (VMP), risk assessments, validation plans, protocols (IQ/OQ/PQ), and summary reports for facilities, utilities, equipment, and processes.

• Plan and execute process validation, cleaning validation, and revalidation activities for drug product manufacturing and packaging operations, ensuring compliance with current regulatory guidance (e.g., FDA Process Validation, EU GMP Annex 1/11, GAMP 5).

• Coordinate and perform qualification activities for new and modified equipment and systems, including drafting and executing URS, DQ, IQ, OQ, and PQ protocols for production and QC laboratory equipment, utilities, and computerized systems (e.g., LIMS, MES).

• Serve as CSV SME (Computerized Systems Validation) for relevant systems, producing and reviewing validation plans, test scripts, requirements traceability, and data integrity controls in line with 21 CFR Part 11 and industry expectations.

• Review and approve validation‑related documents, including SOPs, change controls, deviations, CAPAs, qualification reports, and calibration records, ensuring alignment with GMP and site procedures.

• Analyze validation and qualification data, perform trending and statistical evaluations as needed, and write clear, audit‑ready reports that support validation conclusions and ongoing process capability.

• Act as validation SME during internal, client, and regulatory audits; prepare and defend validation strategies, documentation, and results in collaboration with QA and site leadership.

• Lead or support investigations and root cause analysis related to deviations, non‑conformances, and validation failures; propose and implement CAPAs to prevent recurrence.

• Provide training and mentoring to junior validation engineers/specialists and cross‑functional staff on validation concepts, protocols, and GMP expectations.

• Maintain the validated state of systems and processes through periodic reviews, impact assessments for changes, and timely execution of revalidation activities.

• Stay current with evolving regulations and industry best practices in pharmaceutical validation and CSV; contribute to continuous improvement of the site validation program and standards.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related STEM discipline.

• Minimum 5–7 years of validation experience in the pharmaceutical or biopharmaceutical industry, with significant exposure to manufacturing and packaging environments.

• Demonstrated experience executing and/or leading equipment, utility, and process qualifications (IQ/OQ/PQ), including blending, granulation, compression/encapsulation, coating, liquid mixing/filling, and packaging operations, or comparable unit operations.

• Strong knowledge of cGMP regulations and relevant guidance (e.g., FDA Process Validation, EU GMP Annex 1/11, GAMP 5, 21 CFR Part 11) and their practical application to validation programs.

• Hands‑on experience preparing and reviewing core validation documentation, including VMPs, URS, risk assessments, validation plans, protocols, reports, and change impact assessments.

• Proven ability to manage multiple validation projects simultaneously, prioritize activities, and meet deadlines in a fast‑paced manufacturing environment.

• Excellent written and verbal communication skills, with the ability to explain complex validation concepts to technical and non‑technical stakeholders and to produce clear, audit‑ready documentation.

• Strong interpersonal skills and demonstrated ability to collaborate effectively with QA, Engineering, Operations, IT, and external partners/clients.

Preferred Qualifications

• Master’s degree in Engineering, Pharmaceutical Sciences, or related field.

• Experience in sterile or injectable pharmaceuticals, or in highly regulated dosage forms requiring rigorous process and cleaning validation.

• Significant CSV experience across manufacturing, laboratory, and quality systems (e.g., LIMS, MES, SCADA/DCS), including data integrity and Part 11 compliance.

• Prior client‑facing or CDMO experience, supporting tech transfers, product launches, and external audits.

• Proficiency with statistical tools/software (e.g., JMP or similar) for validation data analysis and process capability assessment.

Core Competencies:

• Technical expertise in pharmaceutical validation and GMP compliance.
• Strong problem‑solving, risk‑based thinking, and root cause analysis skills
• High attention to detail and documentation quality.
• Ownership mindset with ability to drive projects independently while working cross‑functionally
• Continuous improvement orientation, staying current with regulatory and industry developments

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As the SAP S/4HANA O2C Functional Lead, you'll work closely with business stakeholders, architects, and global IT teams to deliver scalable, compliant Order-to-Cash solutions spanning SAP S/4HANA, Global Trade Services (GTS), and FSCM.

You'll translate complex business needs into system design, drive delivery end-to-end, and ensure compliance with global regulatory standards (GxP, SOX) — all while optimizing core O2C workflows including order management, billing, and trade compliance.

What You'll Do

• Own end-to-end delivery of SAP S/4HANA O2C initiatives, ensuring SD, GTS, and FSCM solutions align with enterprise architecture, scalability needs, and broader business objectives.
• Serve as the go-to functional expert for SAP GTS and O2C processes, leading system enhancements, automation efforts, and process optimization across order management and trade compliance.
• Manage system governance and release cycles, ensuring configuration changes and enhancements meet GxP and SOX requirements through structured validation, testing, and documentation.
• Collaborate with global business and IT leadership to shape roadmaps, converting regulatory requirements and commercial strategy into scalable SAP solutions.
• Drive change management and User Acceptance Testing (UAT), ensuring strong user adoption and a smooth handoff to production support teams.

Minimum Qualifications

• Education: Bachelor's degree in Business, Information Technology, or a related field.
• Experience: 5+ years of SAP experience, with hands-on configuration and design work across S/4HANA, SD (Order-to-Cash), and/or GTS.
• Core skills:
  • Strong command of SAP O2C processes (order management, pricing, billing, invoicing).
  • Experience operating in regulated environments (SOX, GxP).
  • Ability to translate complex business requirements into clear, actionable functional design.
  • Strong stakeholder communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting global SAP S/4HANA implementations within Life Sciences, Pharmaceutical, or Animal Health environments.
• Deep familiarity with SAP GTS, FSCM, and trade compliance processes.
• Experience with ITIL frameworks, release management, and vendor coordination.
• Exposure to product-based delivery models and modern SAP landscapes.
• Understanding of commercial operations, distribution, and compliance requirements within regulated industries.
• Ability to work independently in fast-moving, complex environments and deliver data-driven solutions.

Additional Details

• Travel: ~10%.
• Location: Hybrid work environment.

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We are seeking a Pharmacovigilance (PV) Specialist to support the monitoring, assessment, and reporting of adverse events and safety data associated with pharmaceutical or animal health products. This role ensures compliance with global regulatory requirements for drug safety surveillance and contributes to the ongoing evaluation of product safety profiles.

Key Responsibilities

• Receive, process, and evaluate adverse event (AE) reports from various sources (clinical trials, spontaneous reports, literature, regulatory authorities)
• Perform case intake, triage, data entry, and quality review of individual case safety reports (ICSRs) in the safety database
• Assess causality, seriousness, and expectedness of adverse events in accordance with regulatory guidelines
• Prepare and submit regulatory safety reports (e.g., expedited reports, periodic safety update reports (PSURs/PBRERs), DSURs) within required timelines
• Conduct literature surveillance and signal detection activities to identify potential safety concerns
• Support the maintenance and updates of safety documents (e.g., Company Core Data Sheets, Risk Management Plans)
• Ensure compliance with global PV regulations (FDA, EMA, ICH, and other applicable health authority requirements)
• Collaborate with regulatory affairs, clinical, medical, and quality teams on safety-related matters
• Support PV audits and inspections, ensuring documentation and processes are inspection-ready
• Maintain and update standard operating procedures (SOPs) related to pharmacovigilance activities
• Track and trend adverse event data to support ongoing benefit-risk assessments

Required Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field (or equivalent experience); advanced degree a plus
• Experience in pharmacovigilance, drug safety, or a related clinical/regulatory function
• Working knowledge of global PV regulations and guidelines (FDA, EMA, ICH E2 series)
• Experience with safety database systems (e.g., Argus, ArisGlobal, VigiFlow, or similar)
• Strong attention to detail and ability to manage time-sensitive regulatory reporting deadlines
• Strong written and verbal communication skills
• Ability to interpret and apply complex regulatory requirements

Preferred Qualifications

• Certification in pharmacovigilance or drug safety (e.g., Certified in Pharmacovigilance/Drug Safety)
• Experience with signal detection and risk management activities
• Familiarity with MedDRA coding and WHO Drug dictionaries
• Experience supporting regulatory inspections or audits
• Prior experience in animal health, pharmaceutical, or biotech industries
• Experience working in a global, cross-functional PV organization

Core Competencies

• Strong understanding of drug/product safety principles and regulatory compliance
• Analytical mindset for evaluating and interpreting adverse event data
• Cross-functional collaboration with regulatory, clinical, and quality teams
• High attention to detail and accuracy under deadline pressure
• Clear, precise written and verbal communication, including with regulatory authorities

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Solution Architect – Research & Development Systems

As a Solution Architect supporting IT, you'll help lead the digital transformation of a global R&D organization. You'll drive adoption of modern pharmaceutical development platforms — including High-Performance Computing, AI/ML systems, Electronic Lab Notebooks, and Laboratory Execution Systems — to accelerate discovery and development work across bioinformatics, computational chemistry, genomics, and systems biology.

In this role, you'll shape the organization's scientific technology landscape by guiding architecture decisions, influencing technology investment, and aligning solutions with enterprise standards and research innovation goals.

What You'll Do

• Define and deliver the architecture vision for the R&D digital ecosystem, aligned with enterprise architecture principles and technology roadmaps.
• Partner with Product Managers and Principal Engineers to design scalable, compliant, and secure scientific computing solutions.
• Architect and implement integrated R&D systems (ELN, LIMS, LES, CDS, Informatics) using SaaS and cloud-native platforms.
• Apply emerging technologies — AI, cloud-native applications, HPC — to optimize research workflows, data pipelines, and predictive modeling.
• Collaborate across IT and R&D to ensure systems support FAIR data principles and scientific reproducibility.

Minimum Qualifications

• Education: Bachelor's degree in Information Systems, Computer Science, or a related field.
• Experience: 5+ years architecting and delivering enterprise IT systems.
• Key skills:
  • Proven experience supporting pharmaceutical development systems (ELN, LIMS, CDS, LES, Informatics, HPC).
  • Strong technical background integrating SaaS and cloud-native solutions using modern architecture frameworks (API-first, service-oriented, event-driven).
  • Exceptional communication and leadership skills, with the ability to translate complex technical concepts into business value.

Preferred Qualifications

• Experience designing architectures for High-Performance Computing environments and scientific workload management tools (e.g., SLURM, Nextflow).
• Familiarity with FAIR data principles and scientific data lifecycle management.
• Knowledge of regulatory and data integrity requirements in GxP environments (e.g., 21 CFR Part 11).
• Hands-on experience with containerization (Docker, Kubernetes) and modern DevSecOps practices (CI/CD, TDD).
• Solution architecture certification in Microsoft Azure or Google Cloud Platform.

Additional Details

• Travel: Occasional.
• Location: Hybrid work environment.

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As a Senior Scientist within the Mechanistic Biology team, you'll lead novel target identification and validation across multiple disease areas to build out the drug discovery pipeline. This is a non-lab, leadership-focused role guiding cross-functional teams through early-stage drug discovery — leveraging advanced in vitro techniques, integrated AI/ML platforms, and functional genomics. You'll help accelerate the discovery cycle through high-throughput screening approaches that move candidates rapidly from Hit to Lead across both small molecules and biologics.

What You'll Do

• Target Identification & Discovery Innovation: Lead identification and prioritization of novel targets using in vitro/in vivo experiments, literature review, bioinformatics, functional genomics, and AI/ML. Drive iterative "design-test-learn" and active learning cycles to optimize lead compounds and speed up discovery.
• Screening & Digital Discovery: Design and deploy high-throughput, multi-modal screening strategies — biochemical, biophysical, and cellular — to identify new chemical and biological starting points. Apply AI-augmented data analysis, digital phenotyping, and digital discovery platforms to accelerate candidate identification while minimizing experimental costs.
• Cross-Functional Discovery Leadership: Guide cross-functional teams from initial concept through target validation, partnering closely with Computational Sciences, Chemistry, Medicinal Chemistry, Computational Biology, Technical Development, and Preclinical Development. Work with Computational Sciences to build machine learning models for hit expansion and property prediction.
• Target De-risking, Biomarkers & Translational Models: Develop strategies to de-risk targets and strengthen commercial viability, factoring in CMC considerations and assessing on-target/off-target safety risk. Build and integrate biological, AI-enabled, and imaging biomarker strategies alongside translational in vitro disease models — including CRISPR/Cas9-edited primary cell lines and organoids — to speed discovery.
• External Partnerships & Scientific Advancement: Manage external CRO partnerships and biotech collaborations, contributing scientific expertise to discovery campaigns involving DNA-encoded library (DEL), phage display, and yeast display approaches. Cultivate strategic research collaborations and stay current on study design, model development, and New Approach Methodologies (NAMs) to maintain a competitive research edge.

Minimum Qualifications

• Education: Ph.D. in Cell/Molecular Biology, Pharmacology, Biochemistry, or a related field, with several years of postdoctoral training.
• Experience: Industry research experience in early-stage biotech/drug discovery, including CRO management and hands-on work with integrated digital discovery and HTS platforms.
• Core expertise:
  • Target identification and validation, including biological assay development for small and large molecules, and high-throughput validation approaches (e.g., DEL, virtual screening).
  • New Approach Methodologies (NAMs) — organoids/iPSCs and CRISPR/Cas9 screening — with strong proficiency applying AI/ML and deep learning to target validation and phenotypic profiling.

Preferred Qualifications

• 3+ years of experience in a pharmaceutical company, ideally within animal health.
• Demonstrated success identifying novel targets, with a strong publication record.
• Experience with generative AI (e.g., ProteinMPNN) for de novo protein design and affinity maturation.
• Proven ability to lead projects in a fast-paced, agile environment, with strong cross-functional collaboration and influence.
• Working knowledge of relevant statistical principles and data analysis techniques.
• Experience with compound library screening and biomolecular methods (RNA-seq, omics, flow cytometry).

Additional Details

• Travel: Up to 25%.
• Location: Hybrid work environment.

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The Senior Associate, Quality Assurance Validation serves as a key Quality representative supporting capital projects, commissioning, qualification, and computer system validation (CSV) activities at a monoclonal antibody (mAb) manufacturing facility. This role partners closely with engineering, validation, and cross-functional teams to ensure facilities, utilities, equipment, and systems are designed, qualified, and maintained in line with regulatory requirements. The position is central to ensuring data integrity, regulatory readiness, and cGMP compliance across the full lifecycle of capital and validation projects.

What You'll Do

• Provide Quality oversight for capital projects, serving as the QA representative throughout the project lifecycle — from design through qualification and validation. Support design, engineering, commissioning, and qualification of facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
• Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews. Advise engineering and quality teams on qualification and validation strategy to ensure compliance and consistency.
• Support and oversee computer system validation (CSV) activities, contributing to the maintenance and continuous improvement of data integrity processes site-wide. Drive standardization and improvement of equipment and system lifecycle documentation aligned with site operational standards.
• Ensure cGMP and regulatory compliance through Quality review and oversight of site documentation. Support internal audits and regulatory inspections as needed, and help foster a strong "Safety First, Quality Always" culture across all activities.

Minimum Qualifications

• Education: Bachelor's degree in a science or engineering discipline.
• Experience: 5+ years in quality, engineering, or validation roles within the biologics or pharmaceutical industry, including experience with equipment lifecycle management and computer system validation (CSV).
• Core skills: Strong organizational and communication skills with high attention to detail; proven ability to collaborate effectively across cross-functional teams and organizational levels; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications

• Experience in materials management within USDA, FDA, or EMA regulated environments.
• Demonstrated success leading cross-functional teams or projects.
• Experience with SAP, JMP, and Veeva Vault systems.
• Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics.

Additional Details

• Location: Onsite.
• Schedule: Day shift, with occasional weekend or evening work to support operations.
• Travel: Minimal.
• Employment type: Full-time, permanent, salaried.

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R&D Change Management Lead

As the R&D Change Management Lead, you will design and drive change strategies that support R&D initiatives, with an initial emphasis on a data and AI-driven digital transformation. This role plays a key part in helping the R&D organization embrace new working models, strengthen its digital fluency, and progress toward greater organizational maturity.

You will bring a grounded, practical approach to change leadership — starting from where the organization currently stands while guiding leaders and staff toward what's achievable. Working directly with individual contributors, people managers, senior leadership, and executive sponsors, you'll build buy-in, work through resistance, and drive durable shifts in behavior and operations.

You will play a foundational role in building out the change management function within R&D, tailoring established methodologies to fit the organization's specific needs rather than imposing a rigid framework. Success will be measured by real adoption, sustained engagement, behavioral shift, and tangible business results.

What You'll Do

• Develop and implement hands-on change strategies for R&D programs, applying recognized OCM methods through a structured lifecycle — from initial planning through rollout and long-term reinforcement. Collaborate closely with program and project leads, adjusting your approach to match each group's readiness and culture.
• Guide executive sponsors, people managers, and R&D leadership on how to steer their teams through transition. Support leaders in communicating effectively, modeling desired behaviors, resolving obstacles, and holding their teams accountable throughout the process.
• Establish and grow a network of Change Champions spanning R&D functions. Cultivate strong working relationships with champions, prepare them to support their teams, surface pushback and concerns, and help employees connect changes to their daily work.
• Design engaging communication, training, and employee experience initiatives that break down complex changes into actionable steps. Partner with L&D and project stakeholders to build role-specific training that addresses not just what's changing, but why it matters and how employees can thrive under it.
• Track and reinforce adoption by establishing meaningful engagement and adoption metrics, spotting resistance or fatigue early, and translating those insights into corrective steps. Dashboards and reporting should center on genuine employee engagement and demonstrate the tangible value of change efforts.
• Maintain momentum and ownership across change workstreams by setting clear timelines, milestones, and accountability structures. Apply enough project discipline to keep initiatives on track, flag risks proactively, and hold stakeholders to their commitments.

Minimum Qualifications

• Education: Bachelor's degree in Organizational Psychology, Organizational Development, Human Resources, Business, Communications, or a related discipline.
• Experience: Substantial, progressive experience leading Organizational Change Management efforts, including direct ownership of large-scale change within a complex organization. Track record of having personally led multiple significant change initiatives and navigated the real-world friction of organizational adoption.
• Cross-level engagement: Proven ability to operate effectively across every level of an organization — from frontline staff and managers to senior executives and sponsors. Comfortable engaging with concerns, working through resistance, earning trust, and guiding people through transition.
• Change leadership & coaching: Demonstrated skill coaching managers, senior leaders, and executive sponsors through transformation efforts. Able to influence, challenge, and support leadership in communicating clearly, demonstrating expected behaviors, and actively championing change.
• Communication & enablement: Outstanding written and verbal communication skills, with the ability to translate technical, data-driven, or organizational complexity into clear, audience-appropriate messaging. Solid track record building learning and enablement content that drives behavioral adoption.
• Practical approach: High emotional intelligence, strong judgment, and a pragmatic, hands-on problem-solving style. Comfortable simplifying complexity, adapting standard change practices rather than defaulting to rigid methodology, and working in an environment where the change function is still maturing.
• Execution & accountability: Skilled at managing complex initiatives, defining clear milestones and actions, following through on commitments, and holding stakeholders accountable within a matrixed structure.

Preferred Qualifications

• Industry background: Experience in R&D, pharmaceutical, biotech, life sciences, or another technically demanding sector. Familiarity with scientific stakeholders and technical team dynamics is a strong plus.
• Digital transformation exposure: Background supporting major technology, data, analytics, AI, or digital initiatives that required real shifts in behavior and working style to succeed.
• Change networks: Experience building and leading cross-functional Change Champion or change agent networks that meaningfully supported adoption.
• Learning design: Strong background designing practical learning approaches that help staff and leaders build new capabilities and transition smoothly.
• Adoption analytics: Experience setting adoption KPIs and using engagement data and business outcomes to track progress and inform corrective action. Familiarity with dashboarding tools (e.g., Power BI) is a plus but secondary to strong engagement and leadership skills.
• Credentials: Master's degree in a relevant field and/or a formal change management certification (Prosci, CCMP, etc.). Project/program management credentials (PMP, Agile) are valued but not required.
• Capability building: Experience standing up or scaling a change management function from the ground up, including processes, tools, and networks.
• Influence without authority: Ability to build credibility, align stakeholders, and drive outcomes without relying on formal authority.

Additional Details

• Travel: Up to 10%, primarily to R&D sites and key stakeholder locations.
• Location: Flexible — hybrid or remote arrangements considered depending on candidate location and business needs.

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About the Role

Our client, a global life sciences company focused on animal health, is looking for an ML Engineer to help speed up its R&D pipeline. You'll turn proprietary scientific data into predictive models that inform discovery and development decisions. You'll work closely with discovery and development scientists to build machine learning and computer vision models on molecular, in vitro, ADMET and imaging data. These models will support target identification, molecular optimization, digital biomarkers and endpoint prediction.

What You'll Do

• Own the ML and computer vision work on priority R&D programs. You'll work with scientists to turn questions about targets, molecular optimization, in vitro results, ADMET and biomarkers into well-defined modeling problems with measurable success criteria.
• Design, train and validate advanced models, including CNNs, transformers, graph neural networks and generative methods. You'll work across multi-modal data (molecular, assay, imaging and behavioral) to produce reliable predictions and classifications.
• Shape how data is collected and labeled. You'll work with lab teams to define capture protocols, annotation standards and quality checks. You'll also assess synthetic data and augmentation techniques to strengthen sparse datasets while keeping bias and risk under control.
• Put models to work in day-to-day R&D. You'll build and deploy on Databricks, integrate models into the tools scientists already use, and help set standards for reproducibility, documentation, monitoring and model governance.
• Act as a technical leader. You'll mentor junior scientists, drive cross-functional modeling initiatives and explain complex technical results clearly to varied audiences.

Minimum Qualifications

• Education: PhD in a quantitative discipline such as Data Science, Engineering, Physics, Mathematics, Statistics, Bioinformatics or Computational Chemistry. A Master's degree with significant hands-on ML/CV experience will also be considered.
• Experience: 7+ years in industry building and deploying ML and computer vision models for scientific applications in biomedical, pharmaceutical or adjacent fields. You'll need demonstrated impact and a track record of working closely with wet-lab or clinical teams.
• Skills: Strong Python, plus fluency with modern ML/CV libraries such as PyTorch, TensorFlow, scikit-learn and OpenCV. A solid grounding in statistics and experimental design. Proven ability to collaborate and communicate across matrixed, cross-functional teams.

Preferred Qualifications

• Domain impact: Background in animal health, pharma or biotech R&D, with impactful ML/CV work such as chemoinformatics, bioinformatics or digital biomarkers, shown through projects, publications or patents.
• Technical depth: Hands-on experience with neural networks and generative models, and with operationalizing models at scale using Databricks and MLOps tooling.
• Leadership: A record of leading cross-functional teams, mentoring junior scientists and influencing scientific and technical direction in large, global organizations.

Details

• Travel: Up to 10%
• Location: United States (details shared with shortlisted candidates)

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R&D Matrix Project Manager

As the R&D Matrix Project Manager, you will play a pivotal role in advancing the organization's pipeline of innovative veterinary health solutions. You'll collaborate across the global Research and Development function to drive strategic initiatives forward, keeping them on track for timeline and resource targets. In this role, you'll bring consistent, high-caliber project management discipline to the team, helping speed the delivery of products that improve animal health outcomes.

What You'll Do

• Own the delivery of global R&D strategic initiatives from kickoff through close-out, keeping scope, timeline, and budget on track.
• Act as the go-to point of coordination — running project meetings, capturing key decisions, and delivering clear, timely status updates to team members, stakeholders, and executive sponsors.
• Oversee project timelines, risk tracking, and performance metrics using MS Project and other standard project tools to support planning and reporting needs.
• Cultivate relationships and exert influence across cross-functional teams to hit key milestones, get ahead of complex issues, and balance competing priorities within a dynamic matrixed structure.

Minimum Qualifications

• Education: Bachelor's degree (a scientific discipline is preferred).
• Experience: 3–5+ years managing projects within the drug development lifecycle, with working knowledge of the regulatory submission process.
• Core skills: Strong track record influencing cross-functional teams and external partners; proven capability managing intricate project schedules, negotiating effectively, and communicating clearly across all organizational levels.

Preferred Qualifications

• PMP and/or Lean Six Sigma certification.
• Direct experience within veterinary product development.
• Demonstrated ability to quickly pick up and apply new IT systems and tools, with solid AI literacy.
• Prior experience in an operations-oriented role.
• Master's degree in a relevant scientific or business discipline.

Additional Details

• Travel: Up to approximately 10%.
• Location: Hybrid work environment; flexible depending on candidate location and business need.

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About the Role

Our client is a global biopharmaceutical company with a broad portfolio of vaccines and medicines. They are looking for a Clinical Study Manager to run the Canadian operations for global clinical trials. You'll work with global study teams, local cross-functional partners and investigator sites to deliver studies on time, on budget and to a high standard of quality.

This role suits someone who communicates clearly, makes practical decisions, builds trust easily and enjoys developing others. It's a visible leadership role with strong room for career growth.

What You'll Do

• Lead the local study team and coordinate cross-functional contributors on your assigned Canadian studies.
• Run local start-up from beginning to end: feasibility, site selection, regulatory and ethics submissions, and site activation.
• Plan and execute site activation so studies meet their enrollment targets and timelines.
• Manage timelines, budgets and resources. Spot risks early and put mitigation plans in place to keep studies on track.
• Track study progress against agreed metrics, and lead corrective action when performance falls short.
• Manage study-level finances and contribute to site contract and budget negotiations.
• Oversee CRO and vendor performance so it supports study objectives and meets local requirements.
• Keep trial documentation complete and inspection-ready, and support data integrity and GCP compliance.
• Make sure studies follow ICH-GCP, Canadian regulations and internal standards.
• Serve as the main operational link between the global study team and Canadian sites.
• Give global and local stakeholders clear updates on study status, risks and decisions.
• Coach and support local study staff, sharing practical improvements and building the team's capabilities.

Minimum Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, clinical research or a related field, or equivalent experience
• 3+ years in clinical research or clinical study operations
• Project management experience, including oversight of timelines and budgets
• Hands-on experience across the study lifecycle: start-up, recruitment and close-out
• Strong stakeholder management and cross-functional collaboration skills
• Excellent written and spoken English

Preferred Qualifications

• Advanced degree in life sciences, clinical research or a related discipline
• Experience leading multi-site or multi-country studies alongside global central teams
• Experience managing CROs and vendors, including vendor oversight plans
• Working knowledge of Health Canada processes and local ethics submission requirements
• Familiarity with eTMF, CTMS or other clinical operations systems
• Experience supporting audits, inspections or CAPA plans

Working Model

This is a hybrid role based in the Greater Toronto Area. You'll be in the office 2–3 days per week. Fully remote arrangements are not available.

Compensation

The salary range for this role is CAD $117,000–$167,000. Where you land in the range depends on your experience, qualifications and internal equity.

Interested?

We'd love to hear from people who bring scientific curiosity, a collaborative approach and a focus on patients. If this sounds like you, please apply.

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As a Senior Data Scientist, you'll be central to driving innovation and operational efficiency, applying advanced analytics to tackle complex challenges across the full value chain. Sitting within the Enterprise Data Science function, you'll partner with stakeholders across Strategy & Innovation, R&D, Manufacturing, Finance, and Commercial to surface insights, build predictive models, and deliver data-driven solutions that shape both health and business outcomes. This role suits a curious, creative problem-solver energized by turning raw data into real-world impact.

The role centers on four strategic priorities:

• Pipeline Acceleration: Speed up the discovery and approval of high-impact products with a focus on speed, cost, and precision.
• Manufacturing Excellence: Strengthen the efficiency, quality, and consistency of core manufacturing operations — particularly execution and equipment effectiveness.
• Sales Effectiveness: Streamline how teams find, trust, and use customer insights to drive sales growth and stronger engagement.
• Productivity: Grow operating margin by systematically reducing operating costs and improving overall profitability.

What You'll Do

• End-to-End Model Development: Design, build, and validate statistical and machine learning models addressing key business questions — from initial exploration through final analysis.
• Analytical Thought Leadership: Set the standard for analytical rigor, mining large and complex datasets for meaningful insight. Bring an Operations Research lens to optimize decisions and processes.
• Cross-Functional Problem Solving: Partner directly with business units to translate their challenges into data science frameworks — for example: market and competitor analysis for Strategy; accelerating discovery, target identification, clinical trial analysis, and repurposing for R&D; supply chain and yield optimization through predictive quality and maintenance for Manufacturing; margin and profitability analysis for Finance; and forecasting, pricing optimization, campaign personalization, customer behavior analysis, and LLM-driven insight generation for Commercial.
• Actionable Insights: Move beyond model-building to interpret results, synthesize findings, and deliver clear, actionable recommendations to stakeholders at every level.
• Data Storytelling: Turn complex analytical findings into compelling, easy-to-follow narratives using strong visualization and communication skills.
• Deployment Collaboration: Work closely with Data, AI, and ML Engineers to ensure models are successfully embedded into business processes and applications.
• Driving Innovation: Stay current on emerging methodologies in ML, statistics, and AI, and apply them to keep the organization's data science practice ahead of the curve.
• Building a Data-Driven Culture: Mentor and educate colleagues on data science principles and best practices to embed a stronger data-driven mindset across the organization.

Minimum Qualifications

• Education: Master's or PhD in a quantitative discipline — Data Science, Statistics, Computer Science, Operations Research, or similar.
• Experience: 12+ years in Data Science or closely related work.
• Programming: Strong Python or R skills, with fluency in data manipulation and machine learning libraries.
• Statistical foundation: Solid grounding in statistical principles and experimental design, including hypothesis testing, regression, and classification.
• Machine learning: Proven track record applying diverse ML techniques (gradient boosting, clustering, NLP, time-series forecasting, etc.) to real-world problems.
• Visualization & communication: Skilled at using visualization tools to tell compelling stories and explain complex concepts to non-technical audiences.

Preferred Qualifications

• Finance domain knowledge: Solid grasp of financial data, forecasting, budgeting, profitability, and performance analytics.
• Business acumen: Quick to grasp business challenges and connect insights to strategic goals; experience in animal health, pharma, manufacturing, or commercial analytics is a strong plus.
• Industry depth: Strong understanding of the life sciences business model, regulatory/compliance landscape, and associated risks — with the ability to identify and act on data science opportunities that support life science outcomes.
• Database skills: Proficient in SQL for querying and extracting data from relational databases.
• Cloud experience: Familiarity with public cloud platforms — especially Azure and GCP — and their data/analytics services is highly desirable.

Additional Details

• Location: Hybrid work environment.
• Travel: Minimal.

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As an R&D Project Manager, you'll serve as a strategic partner to project leaders, guiding complex global R&D programs from concept through completion. Operating at the intersection of science and project execution, you'll work with global teams spanning Regulatory, Manufacturing, R&D, and Marketing. This role is critical to building and executing robust, proactive project plans that manage risk and drive successful delivery across the R&D portfolio. It calls for a strategic thinker equally comfortable with macro-level planning and micro-level execution in support of novel scientific development.

What You'll Do

• Strategic Project & Scope Management: Serve as a strategic partner to project leaders, independently managing the full scope of project management activities for complex, high-impact development programs. Guide delivery by managing schedules, costs, and performance risk; run scenario planning to build realistic milestones; and maintain scope documentation aligned to strategic goals.
• Timeline & Performance Oversight: Own the project plan end-to-end, including up-to-date timelines and process maps. Identify, manage, and communicate the critical path and leading indicators, monitor performance against plan, and proactively steer the team to stay on track — ensuring data accuracy and completeness across all systems.
• Budget & Financial Partnership: Partner with Finance, functional teams, and regional stakeholders to manage the program's overall development budget. Work with the development team to understand and report variances, drive re-forecasts, keep budget data current in relevant tools, and give the team visibility into the cost implications of different development paths.
• Proactive Risk & Contingency Planning: Lead comprehensive risk assessments for development programs, establishing clear mitigation and contingency plans with defined ownership. Proactively flag risks that could impact the critical path and independently activate contingency plans as needed.
• Process Improvement & Shared Learning: Champion a culture of quality and continuous improvement by proposing new processes and sharing lessons learned across the team and function. Identify ways to streamline effectiveness, shorten development cycle times, and drive consistent use of PM tools and concepts to maximize business value.

Minimum Qualifications

• Education & Experience: Bachelor's or Master's degree in a scientific or related field, with 8–10 years of relevant experience in project management or a related scientific role.
• Scientific & regulatory depth: Strong understanding of the veterinary (or pharmaceutical) drug development process, including the interdependencies across global teams, functional groups, and third parties. Demonstrated experience with regulatory submission processes and requirements, along with solid grounding in GCP, GLP, and GMP quality principles.
• PM & technical proficiency: Demonstrated command of core project management fundamentals per PMBOK. Strong technical skills with project management software, Microsoft Office, and emerging AI tools.
• Cross-functional influence & leadership: Proven ability to influence without direct authority and guide global, cross-functional teams through ambiguity. Strong interpersonal and team-building skills, with a track record of developing effective teams across diverse working styles and delivering constructive coaching and feedback.
• Problem-solving & adaptability: Proactive, anticipatory approach to problem-solving — able to spot systemic issues, diagnose root causes, and implement corrective action to prevent recurrence. Comfortable adjusting quickly to shifting priorities and frequent change.

Preferred Qualifications

• PMP or CAPM certification.
• Direct experience in the Animal Health industry.
• Growth mindset and curiosity, with eagerness to ask questions and learn quickly.
• Proven ability to work effectively both independently and as part of a highly collaborative team.

Additional Details

• Travel: Up to 10% annually.
• Location: Hybrid work environment.

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We are seeking a Bioinformatics/Computational Biologist to analyze complex biological datasets, develop and apply computational methods, and support research and development efforts through data-driven insights. This role bridges biology, statistics, and computer science, working closely with wet-lab scientists, data scientists, and R&D teams to translate large-scale biological data into actionable findings.

Key Responsibilities

• Design, develop, and apply bioinformatics pipelines and computational tools to analyze genomic, transcriptomic, proteomic, and/or other omics data
• Perform statistical analysis and data mining on large-scale biological datasets (NGS, microarray, sequencing data, etc.)
• Develop and maintain software, scripts, and workflows for data processing, quality control, and analysis
• Collaborate with laboratory scientists to design experiments and interpret computational results in a biological context
• Build and maintain databases and data management systems for biological research data
• Apply machine learning, statistical modeling, and/or algorithm development to biological research questions
• Visualize and communicate complex analytical results to both technical and non-technical stakeholders
• Stay current with emerging tools, methods, and literature in bioinformatics and computational biology
• Document methods, workflows, and results in accordance with research and regulatory standards
• Contribute to publications, patents, and internal reports as needed

Required Qualifications

• Master's or Ph.D. in Bioinformatics, Computational Biology, Genomics, Computer Science, Statistics, or a related field (or equivalent experience)
• Proficiency in programming languages such as Python, R, or similar
• Experience with bioinformatics tools and pipelines (e.g., BLAST, GATK, Bioconductor, Nextflow, Snakemake)
• Strong understanding of molecular biology and genetics fundamentals
• Experience working with next-generation sequencing (NGS) data and associated analysis workflows
• Familiarity with Linux/Unix environments and high-performance/cloud computing (AWS, GCP, or similar)
• Strong statistical analysis skills
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience with machine learning/deep learning applied to biological data
• Familiarity with SQL and database management
• Experience with version control (Git) and reproducible research practices
• Knowledge of regulatory or GxP environments (pharma/biotech/animal health settings)
• Prior experience in a relevant industry (pharmaceutical, animal health, agbio, biotech)
• Publication record in relevant scientific journals

Core Competencies

• Analytical and problem-solving mindset
• Ability to work cross-functionally with lab scientists, data engineers, and leadership
• Attention to detail and rigorous, reproducible methodology
• Comfort working independently in a fast-paced, evolving research environment

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We are seeking an AI Governance Specialist to help establish, implement, and maintain frameworks that ensure the responsible, ethical, and compliant use of artificial intelligence and machine learning systems across the organization. This role bridges technical, legal, risk, and compliance functions to manage AI-related risk while enabling innovation.

Key Responsibilities

• Develop and maintain AI governance frameworks, policies, and standards covering the AI/ML model lifecycle
• Assess AI/ML systems for risk, including bias, fairness, explainability, robustness, privacy, and security considerations
• Support model risk management processes, including model inventory, validation, and ongoing monitoring
• Monitor and interpret evolving AI regulations and standards (e.g., EU AI Act, NIST AI Risk Management Framework, sector-specific guidance) and assess organizational impact
• Collaborate with data science, engineering, legal, compliance, and risk teams to embed governance controls into AI development processes
• Support AI impact assessments and risk reviews for new AI use cases prior to deployment
• Maintain documentation supporting AI system audits, regulatory inquiries, and internal reviews
• Contribute to the development of responsible AI principles, ethical guidelines, and review processes
• Track and report on AI governance program metrics, model inventory status, and identified risks
• Support training and awareness initiatives on responsible AI practices across the organization
• Stay current with emerging AI governance frameworks, regulatory developments, and industry best practices

Required Qualifications

• Bachelor's degree in Law, Data Science, Computer Science, Public Policy, Risk Management, or a related field (or equivalent experience)
• Experience in AI/ML governance, model risk management, technology risk, or regulatory compliance
• Understanding of AI/ML concepts, model development lifecycle, and associated risks (bias, explainability, robustness)
• Familiarity with emerging AI regulations and frameworks (EU AI Act, NIST AI RMF, ISO/IEC 42001, or similar)
• Strong analytical and critical-thinking skills to assess risk across technical and business contexts
• Excellent written and verbal communication skills, with ability to translate technical concepts for non-technical stakeholders
• Experience developing or contributing to governance policies, standards, or documentation

Preferred Qualifications

• Experience with model risk management frameworks (e.g., SR 11-7 or equivalent) in a regulated industry
• Familiarity with responsible AI tools (bias detection, explainability, model monitoring platforms)
• Certification in AI governance, privacy, or risk management (e.g., AIGP, CIPP, CRISC)
• Experience working directly with data science/ML engineering teams on model development processes
• Legal or regulatory background with a focus on technology or data privacy
• Prior experience in a regulated industry (financial services, healthcare, pharma)

Core Competencies

• Strong understanding of AI/ML risk and governance principles
• Ability to work cross-functionally across legal, technical, risk, and compliance teams
• Analytical and structured approach to risk assessment
• Clear communication bridging technical and non-technical audiences
• Adaptability given the fast-evolving nature of AI regulation and technology

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Cybersecurity Specialist

As a Cybersecurity Specialist, you'll play a key role in protecting the organization's systems, data, and infrastructure from evolving cyber threats. You'll work across IT, R&D, and business teams to strengthen security posture, monitor for risk, and ensure the organization's technology environment stays resilient, compliant, and secure as it scales.

This role suits someone who's equal parts technical and collaborative — comfortable diving into logs and threat intel one moment, and explaining risk to non-technical stakeholders the next.

What You'll Do

• Monitor, detect, and respond to security incidents across networks, endpoints, cloud environments, and applications, escalating and remediating threats as they arise.
• Conduct vulnerability assessments and penetration testing to identify gaps, and partner with IT and engineering teams to remediate findings.
• Maintain and improve security tooling — SIEM, EDR, firewalls, IAM systems — ensuring configurations reflect current best practices and threat landscape.
• Support security compliance efforts (e.g., SOC 2, ISO 27001, PIPEDA, or industry-specific frameworks), including audits, documentation, and control validation.
• Develop and enforce security policies, standards, and procedures, and help drive security awareness training across the organization.
• Partner with architecture and engineering teams to embed security-by-design principles into new systems, applications, and infrastructure projects.
• Track emerging threats, vulnerabilities, and industry trends, translating them into proactive risk mitigation strategies.

Minimum Qualifications

• Education: Bachelor's degree in Computer Science, Information Security, or a related field (or equivalent practical experience).
• Experience: 3–5+ years in a cybersecurity, information security, or IT security role.
• Core skills:
  • Hands-on experience with security monitoring tools (SIEM, EDR/XDR, IDS/IPS).
  • Solid understanding of network security, cloud security (Azure, AWS, or GCP), and identity/access management.
  • Familiarity with common frameworks and standards (NIST, ISO 27001, CIS Controls).
  • Strong analytical and troubleshooting skills, with the ability to communicate risk clearly to technical and non-technical audiences.

Preferred Qualifications

• Relevant certifications such as CISSP, CompTIA Security+, CEH, or GIAC certifications.
• Experience in a regulated industry (finance, healthcare, life sciences, or similar).
• Familiarity with Canadian privacy and data protection regulations (PIPEDA) and cross-border data handling considerations.
• Experience with incident response planning and tabletop exercises.
• Scripting or automation experience (Python, PowerShell) to streamline security operations.
• Exposure to DevSecOps practices and integrating security into CI/CD pipelines.

Additional Details

• Travel: Minimal.
• Location: Toronto, ON — hybrid work environment.

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As a Regulatory Affairs Specialist, you'll be a key contributor to the Canadian Regulatory Affairs team, supporting registration and lifecycle management across a diverse animal-health product portfolio. You'll lead regulatory submissions, shape labelling strategy, prepare dossiers, engage directly with Canadian regulatory authorities, and help maintain compliance and consistency across global and local product information.

What You'll Do

• Lead the preparation and execution of high-quality regulatory submissions for innovation projects, post-approval activities, product variations, and labelling changes.
• Manage relationships with Canadian regulatory authorities, including the Canadian Centre for Veterinary Biologics, and support the broader regulatory relationship strategy for the Canadian business.
• Coordinate global and local change-control activities, ensuring timely submission of variations and effective lifecycle management of marketed products.
• Advise the Canadian affiliate and launch teams on product registration, regulatory intelligence, labelling strategy, and local advertising requirements for promotional materials.
• Partner with Global Regulatory, Pharmacovigilance, Sales and Marketing, Supply Chain, and Quality teams to deliver compliant outcomes across multiple concurrent projects and timelines.

Minimum Qualifications

• Education: Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related scientific discipline.
• Experience: 7+ years in Regulatory Affairs within the pharmaceutical or animal health industry.
• Regulatory knowledge: Thorough command of the Canadian Food and Drugs Act, Food and Drug Regulations, and GMP Regulations, along with the Canadian frameworks governing veterinary biologics, drugs, feed, and pesticides.
• Communication: Strong written and verbal communication skills, with the ability to coordinate cross-functional teams, represent the organization in interactions with regulatory authorities, and maintain close attention to detail in technical documentation.

Preferred Qualifications

• Experience in the Animal Health industry.
• Experience managing submissions through the Canadian Centre for Veterinary Biologics.
• Experience with emerging biotechnology platforms or biotechnology-related regulatory submissions.
• Demonstrated ability to lead complex regulatory projects end-to-end, flagging risks and concerns early.
• Track record of applying innovative thinking to regulatory challenges and driving continuous improvement.

Additional Details

• Travel: Up to 10%.
• Location: Mississauga, Ontario, Canada.
• Work model: Hybrid.

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We are seeking a Biomanufacturing Engineer to support the design, optimization, scale-up, and operation of biological manufacturing processes. This role works cross-functionally with process development, quality, and operations teams to ensure the safe, compliant, and efficient production of biologic products (e.g., vaccines, biologics, cell/gene therapies, or animal health products).

Key Responsibilities

• Support design, development, and optimization of upstream and/or downstream bioprocessing operations (fermentation/cell culture, purification, filtration, filling)
• Lead or support technology transfer and scale-up activities from process development to commercial manufacturing
• Troubleshoot manufacturing process deviations and drive root-cause investigations and corrective actions (CAPA)
• Author and review batch records, SOPs, process validation protocols/reports, and other manufacturing documentation
• Ensure manufacturing processes comply with cGMP, regulatory, and quality standards
• Collaborate with Quality, Process Development, Facilities, and Automation teams on equipment qualification and process validation
• Monitor and analyze process data to identify opportunities for yield, efficiency, and quality improvements
• Support commissioning, qualification, and validation of new or modified manufacturing equipment and systems
• Participate in continuous improvement initiatives (Lean, Six Sigma) to optimize manufacturing operations
• Support regulatory inspections and audits as a subject matter expert on manufacturing processes

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biology, or a related field (or equivalent experience)
• Experience in biomanufacturing, bioprocessing, or biopharmaceutical production environments
• Understanding of upstream and/or downstream bioprocessing unit operations
• Familiarity with cGMP regulations and quality systems in a regulated manufacturing environment
• Strong technical writing skills for authoring manufacturing and validation documentation
• Ability to troubleshoot and resolve process and equipment issues
• Strong attention to detail and commitment to safety and compliance

Preferred Qualifications

• Experience with specific modalities (mammalian cell culture, microbial fermentation, cell/gene therapy, vaccines)
• Experience with process validation and technology transfer projects
• Familiarity with manufacturing execution systems (MES), DeltaV, or other automation/control platforms
• Six Sigma/Lean certification or process improvement experience
• Experience supporting regulatory inspections (FDA, EMA, or other health authorities)
• Prior experience in pharmaceutical, biotech, or animal health manufacturing

Core Competencies

• Strong understanding of GMP manufacturing and quality principles
• Cross-functional collaboration with Quality, Process Development, and Operations
• Analytical and root-cause problem-solving skills
• Ability to work in a fast-paced, regulated production environment
• Clear written and verbal communication, including with auditors/regulators

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