Senior Director, Regulatory Science (CMC)
Somerville, Massachusetts, United States
Minimum Qualifications:
- Ph.D. and 12+ years of relevant biopharmaceutical industry experience, or M.S. with 15+ years of experience.
- At least 5 years of experience in a CMC-focused regulatory science role, preferably for the development of gene therapies, oligonucleotides, or biologics.
- Recent experience in successfully leading CMC-related regulatory interactions, and in IND/CTA or BLA/MAA regulatory submissions and approvals.
- Proven success in delivering effective global regulatory CMC strategies and in leading a regulatory CMC team.
- Excellent written and oral communication and interpersonal skills.
- Thorough understanding of CMC drugs and biologics regulations and guidelines including ICH, FDA, and EMA guidelines. Strong knowledge of current Good Manufacturing Practices (GMP).
- Well-versed in regulatory and technical writing.
- Independently motivated, detail-oriented, and scientifically rigorous.
Responsibilities:
- Developing robust CMC regulatory strategies for all Tessera's development programs, anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues.
- Leading discussions with regulatory agencies to resolve CMC issues as well as shepherding proactive interactions with regulators globally.
- Overseeing planning, preparation, and submission of high-quality regulatory CMC dossiers.
- Providing regulatory CMC guidance to internal teams and leading cross-functional teams to prepare briefing packages, Module 3, and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
- Assessing regulatory impact of proposed manufacturing process changes.
- Tracking regulatory CMC commitments; managing ongoing regulatory submissions and future reporting requirements, including annual reports.
- Effectively building, maintaining, and motivating a high-performing regulatory CMC team.
- Maintaining knowledge of the global regulatory CMC environment and applicable regulations and guidelines.
- Supporting Quality and CMC teams during GMP inspections.
About You:
You are an experienced Senior Director in Regulatory Science, specialized in Chemistry Manufacturing and Control (CMC) for biologics. You are excited about leading the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs and CTAs, in close collaboration with regulatory team members, CMC and Quality teams, contract manufacturing organizations, external experts, and global health authorities.
Tessera employees are creative and collaborative problem solvers with a strong sense of integrity and commitment to scientific excellence.
Company Summary:
Tessera Therapeutics is pioneering Gene Writing—a new biotechnology designed to offer scientists and clinicians the ability to write therapeutic messages into the genome, thereby curing diseases at their source. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise.
Equal Opportunity Employment:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by applicable laws.
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