Senior Director, Regulatory Science (CMC)
: Job Details :

Your experience includes…

• 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 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.
• 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 involvement within a growing company environment while recognizing when to delegate and empower the team.
• It's a bonus if you have 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.

You are interested in…

• 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 to refine CMC development strategies.
• Overseeing planning, preparation, and submission of high-quality regulatory CMC dossiers; this will require a good understanding of the underlying science.
• Providing 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.
• Assessing regulatory impact of proposed manufacturing process changes.
• Tracking regulatory CMC commitments; managing on-going regulatory submissions and future reporting requirements, including annual reports.
• Effectively building, maintaining, and motivating a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring a diverse, talented and driven staff.
• Actively participating in building an outstanding regulatory team, leveraging operational excellence to efficiently implement innovative regulatory strategies.
• Maintaining knowledge of global regulatory CMC environment, and applicable regulations and guidelines. Leading reg-CMC intelligence activities.
• 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 who is interested in being responsible for the development and management of the regulatory CMC strategy for multiple gene therapy programs that are in the early stages of development. 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, our in‐house CMC and Quality teams, contract manufacturing organizations, external experts and global health authorities. You are a driven individual who is comfortable multitasking and working independently, and are ready to join a dynamic, rapidly growing, and highly collaborative team.

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.

Meet your Manager:

Narin Ahmed, Vice President, Regulatory Science

Meet your Talent Partner:

Annie Edminster, Employee Experience and Talent Lead

Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.

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.

More about Tessera Therapeutics:

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 federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or ...@tesseratx.com

Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics' internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.