Senior ScientistPurpose & Scope Lead and manage drug product readiness activities for cell therapy programs through the development and optimization of formulations, manufacturing processes, and control strategies to support product development, regulatory submissions, and manufacturing readiness.
Plan, evaluate, and execute development studies required to support process readiness, technology transfer, process validation, and regulatory submissions across all stages of cell therapy product development.
Enable successful commercialization of cell therapy products through the generation of scientific evidence and technical justifications to support regulatory filings and successful advancement of cell therapy programs.
Role and Responsibilities - Lead formulation, process development, process characterization activities and CMC strategies as part of a multi-team structure supporting cell therapy drug product development and regulatory submissions from IND through commercialization.
- Design, execute, and interpret studies required to support process readiness, technology transfer, process validation, regulatory submissions, and lifecycle management.
- Identify product, process, and CMC readiness gaps; assess risks and develop mitigation plans to support product development and regulatory readiness.
- Generate scientific rationales, risk assessments, technical reports, and CMC data packages to support regulatory submissions, agency interactions, and regulatory inspections.
- Partner with Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, and external organizations to ensure successful technology transfer and lifecycle management.
- Author, review, and approve technical documents, protocols, reports, and regulatory submission content.
- Drive continuous improvement initiatives to enhance product quality, process robustness, manufacturability, and operational efficiency.
- Provide technical leadership and mentorship to junior scientists, research associates and project teams.
Required Qualifications - BS/MS or Ph.D in a life science; BS with 12+ years, MS with 8+ years or Ph.D with 5+ years of highly relevant experience in biotechnology or pharmaceuticals industry.
- Broad knowledge of cell therapy and/or biologics product development and pharmaceutical sciences, and GMP manufacturing principles.
- Experience in drug product development, including formulation development, manufacturing process development, control strategy development and technology transfer
- Experience supporting regulatory submissions, including preparation of CMC documentation and scientific data packages for IND/CTA and BLA/NDA or equivalent submissions.
- Demonstrated ability to identify development challenges, assess product and process risks, and develop data-driven mitigation strategies.
- Strong understanding of global regulatory expectations and guidelines applicable to biologics and cell therapy products, including FDA, ICH, PIC/S, and EU GMP.
- Experience supporting GMP manufacturing operations, including aseptic processing and sterile drug product manufacturing
- Excellent verbal and written communication skills, with the ability to effectively lead and influence cross-functional teams.
Preferred Qualifications - Experience supporting development of cell therapy drug products across multiple stages of development.
- Experience developing product and process understanding through formulation robustness studies, process characterization studies, risk assessments, comparability assessment, and risk evaluation to support product development and manufacturing change.
- Experience generating scientific data packages and technical justifications to support product development, regulatory submissions, and lifecycle management.
- Experience with raw material qualification, container closure systems, extractables and leachables (E/L) assessments, and control strategy development.
- Experience supporting technology transfer, process validation, and manufacturing readiness activities with internal manufacturing sites, CDMOs/CMOs, and external partners.
- Knowledge of Quality by Design (QbD), risk management principles, and pharmaceutical development approaches.
- Experience supporting regulatory inspections, agency interactions, and responses to health authority questions and serving as an author or primary contributor to CMC sections of regulatory submissions.
- Demonstrated ability to lead cross-functional teams and influencing development, manufacturing, quality, and regulatory strategies.
Location and Working Environment- This position is based at Westborough, MA and is a primarily on-site based position.
Salary Range$119,000-$170,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits:- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program
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