What We Do:
Ambrx Biopharma, Inc. is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.
How will you contribute to our mission:
The Senior Director, CMC Regulatory Affairs will be responsible for developing the global Regulatory CMC strategy for the Ambrx portfolio, specifically on ARX517 and ARX788. The candidate will serve as the regulatory CMC lead on the cross functional teams, working closely with key stakeholders, specifically with the Technical operations team to execute the strategies in alignment with business priorities. She/he will also be required to construct and draft CMC documents for regulatory submissions (IND, BLA, and briefing packages as required).
The individual will be expected to actively participate in cross-functional governance teams for topics relevant for products in their portfolio. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Effective communication skills will be critical to overall success.
The Sr Director Regulatory CMC will be part of a high-performing team that is passionate about focused drug development contributing towards positively impacting the patients we serve.
- Lead the development and implementation of robust CMC regulatory strategies for the Ambrx portfolio, by anticipating/identifying regulatory risks and/or opportunities
- Lead discussions with regulatory agencies to facilitate review and approval that ensure global alignment on CMC development strategies
- Oversee the review of high quality regulatory CMC dossiers based on prior and current knowledge of the GTx environment and landscape
- Track Regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
- Develop regulatory processes and procedures to support CMC components of regulatory submissions
- Support Quality and CMC team during GMP inspections
- Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls
- Provides interpretation of domestic and international regulatory guidance documents, regulations and directives advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
- Participate in external trade organizations, related industry conferences, and evaluate opportunities to engage with health authorities to be at the forefront of evolving regulations
What you will need for consideration:
- MS/PhD degree in a scientific/engineering discipline
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions, preferably in Biologics
- Attention to detail, ability to work on multiple projects with tight timelines without compromising quality
- Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
- Has successfully led responses to health authorities • Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each programs critical regulatory milestones
- Exceptional written and oral communication
The pay scale for this position is: $250,000- $300,000 commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.
As an equal opportunity employer, Ambrx is committed to a diverse workforce. Ambrx will consider all qualified applicants without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.