Senior Director, Regulatory Science, CMC

Company Summary:

Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

Position Summary:

We are seeking an experienced Senior Director in Regulatory Science specialized in Chemistry Manufacturing and Control (CMC) for biologics who will be responsible for the development and management of the Regulatory CMC group and for providing regulatory CMC strategic leadership to support multiple gene therapy programs both in the US and internationally in the early stage of development. 

This senior position will be responsible for 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, our in‐house CMC and Quality teams, contract manufacturing organizations, external experts and global health authorities.

The successful candidate will be a driven individual who is comfortable multitasking and working independently. This individual will join a dynamic, rapidly growing, and highly collaborative team.

Key Responsibilities:

• Development of robust CMC regulatory strategies for all Tessera development programs, anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues.
• Lead discussions with regulatory agencies to resolve CMC issues as well as shepherd proactive interactions with regulators globally to refine CMC development strategies.
• Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers; this will require a good understanding of the underlying science.
• Provide regulatory CMC guidance to internal teams and lead cross-functional teams to prepare, briefing packages, Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
• Assess regulatory impact of proposed manufacturing process changes.
• Track regulatory CMC commitments; manage on-going regulatory submissions and future reporting requirements, including annual reports.
• Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring a diverse, talented and driven staff.
• Actively participate in building an outstanding regulatory team, leveraging operational excellence to efficiently implement innovative regulatory strategies.
• Maintain knowledge of global regulatory CMC environment, and applicable regulations and guidelines. Lead reg-CMC intelligence activities. 
• Support Quality and CMC team during GMP inspections.

Qualifications:

• Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required, Ph.D. desirable.
• Minimum of 10 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused regulatory science role, preferably for the development of gene therapies, oligonucleotides, or biologics
• Prior subject matter expertise and work experience in a CMC technical role to develop advanced therapy or biologics preferred; experience in projects involving scale-up, comparability, and expedited pathways is considered a plus.
• 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.
• Retains optimism and energy in the face of change and challenges; eagerness to problem solve and influence outcomes.
• Ability to incorporate multiple viewpoints to create optimal strategy forward.
• Independently motivated, detail oriented and scientifically rigorous.
• A "hands-on", "roll-up-the-sleeves"-when-necessary leader who understands the need for involv