Advance biologics from development through commercial readiness as a technical leader overseeing drug product operations, GMP manufacturing execution, and external CDMO partnerships. In this onsite role in Boston, MA, you will help move Dechra’s biologics pipeline forward by combining hands-on manufacturing oversight with end-to-end support for technology transfer, validation, and launch preparation.
This position reports to the Director, Biologics Drug Product Operations and is accountable for managing Contract Development and Manufacturing Organizations (CDMOs). You will also support technology transfer, process characterization, process validation, Process Performance Qualification (PPQ), and collaboration with Manufacturing and Supply to support commercial launch readiness. During critical operations, you will serve as Person-in-Plant (PiP) to provide onsite technical leadership, resolve issues quickly, and oversee readiness activities, including batch record review, investigations, and validation.
What you’ll do
- Act as the primary operational lead for external drug product CDMOs and manufacturing partners, building relationships to ensure successful execution of clinical, PPQ, and commercial GMP manufacturing programs.
- Manage clinical-stage CDMO performance including contractual deliverables, manufacturing schedules, budgets, and risk mitigation plans aligned to development and commercial objectives.
- Provide onsite leadership as PiP during critical manufacturing, process validation, and PPQ campaigns, supporting rapid issue resolution.
- Deliver technical oversight across early to late clinical stage biologics drug product development, manufacturing operations, process validation, and commercial readiness activities.
- Lead and support technology transfer, process characterization, validation strategy development, and PPQ readiness programs.
- Identify manufacturing and process risks and implement mitigation strategies to support successful execution and regulatory compliance.
- Coordinate PPQ planning and execution, including manufacturing readiness assessments, campaign oversight, data review, and support for validation report preparation.
- Review and approve manufacturing and validation documentation such as protocols, technical reports, manufacturing proposals, batch records, deviations, investigations, CAPAs, and change controls.
- Ensure manufacturing activities follow cGMP requirements and applicable regulatory expectations.
- Support preparation and review of CMC documentation for regulatory submissions, inspections, agency interactions, and responses to health authorities.
- Collaborate with CMC Development, CMC Operations, Manufacturing and Supply, Quality, Regulatory Affairs, Clinical Operations, and external partners to meet program milestones and business objectives.
- Drive stakeholder alignment to ensure timely execution of manufacturing campaigns, regulatory commitments, and supply plans.
- Support establishment and maintenance of quality agreements, master service agreements, statements of work, and other strategic partnerships with external providers.
- Champion continuous improvement initiatives to enhance operational performance, product quality, supply reliability, compliance, and CDMO effectiveness.
- Promote a culture of accountability, collaboration, innovation, and operational excellence across internal and external teams.
- Represent Dechra professionally and ethically by demonstrating integrity, respect, determination, and commitment to company values.
What you bring
- Bachelor, Master, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or a related science.
- Extensive biotechnology or pharmaceutical industry experience with significant experience in biologics drug product development and manufacturing.
- Understanding of biologics drug product manufacturing including aseptic processing, fill-finish operations, packaging, labelling, storage, and distribution.
- Demonstrated experience supporting late-stage clinical and commercial manufacturing programs.
- Experience managing external CDMOs for GMP drug product manufacturing.
- Experience serving as Person-in-Plant (PiP) during GMP manufacturing campaigns.
- Experience reviewing and approving CMC technical development documents.
- Understanding of process validation principles and lifecycle management.
- Working knowledge of PPQ planning, readiness activities, execution, and reporting.
- Ability to travel (domestic/international) approximately 25–40%.
Nice to have
- Passion for animal-health and getting innovative veterinary medicines to market.
- Knowledge of animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies.
- Working knowledge of current regulations and industry trends for large molecule DP product development and manufacturing.
- Experience supporting commercial product launches.
- Knowledge of sterile manufacturing operations and Annex 1 requirements.
- Working knowledge of lean and/or six sigma operations.
Compensation: USD 145,000 - 170,000 per year.