Executive Director, Regulatory Science (CMC)

Your experience includes Master's degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required, Ph.D. desirable. Minimum of 16 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC-focused regulatory science role. 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). Being well-versed in regulatory and technical writing. Retaining optimism and energy in the face of change and challenges; eagerness to problem-solve and influence outcomes. The ability to incorporate multiple viewpoints to create optimal strategy forward. Being independently motivated, detail oriented and scientifically rigorous. Experience as 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 such as gene therapies, oligonucleotides, or biologics. Experience in projects involving scale-up, comparability, and expedited pathways. You are interested in Developing robust CMC regulatory strategies for all Tessera development programs and anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues. Communicating CMC regulatory program strategies with functional heads and executive team members. Leading discussions with regulatory agencies to resolve CMC issues as well as shepherding 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. 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 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 participate 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. Support Quality and CMC teams during GMP inspections. About you: You are an experienced Executive Director in Regulatory Science with specialized experience in Chemistry Manufacturing and Controls (CMC) for biologics who is excited about being 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. As a senior member of the team, you 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. At Tessera, you will find a highly collaborative, matrixed environment defined by rapid scientific innovation and a mission-driven culture dedicated to transforming the lives of patients with devastating genetic diseases. You will make our mission possible by implementing state-of-the-art approaches to achieve operational excellence, optimize clinical trial efficiency, and accelerate the development of our gene therapies. Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves. Leadership Structure: Meet your Manager: All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening. Narin Ahmed, Vice President, Regulatory Science Originally from Canada, Narin Ahmed earned her Doctor of Pharmacy degree from Temple University. With over a decade of experience in regulatory affairs, Narin has led key drug development projects in hematology, oncology, and autoimmune diseases, including being the U.S. lead for Kymriah® and the global lead for Abecma®. She is passionate about guiding cross-functional teams through the complex world of cell and gene therapies and advancing innovative treatments for patients. Narin lives in New Jersey with her two children and loves to travel, having been to 55 countries. Meet our Leadership Team and Board of Directors Meet your Talent Partner: Annie Edminster, Employee Experience and Talent Lead Originally from Maine, Annie obtained her Bachelor of Science from Syracuse University. She spent eight years in Biotech, Engineering and Tech agency recruitment, then joined Tessera in 2022. Annie loves watching her new hires grow in their careers and getting to know her colleagues from all over the world She lives in New Hampshire with her robot-building husband, two feisty daughters, and two Siberian cats. 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 Accommodationstesseratx.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.