Associate Director/Director, CMC

Associate Director / Director - CMC (Chemistry, Manufacturing, and Controls)
Location: Brisbane, CA
Department: R&D
Employment Type: Full-Time, On-site

OPPORTUNITY

We are seeking an Associate Director / Director, CMC to be a key player in our product development teams, providing support across all developmental and clinical programs. The successful candidate will manage a network of CDMOs for Drug Substance and Drug Product manufacturing for our pipeline.

KEY RESPONSIBILITIES

Associate Director Level:

1. Design, develop, and validate analytical methodologies for our pipeline.
2. Identify opportunities to improve productivity and efficiency in projects and analytical science.
3. Collaborate with diverse teams, including CDMO analytical science teams.
4. Lead analytical science in project teams, ensuring alignment and fostering productive relationships with other core functions.
5. Ensure data integrity and promote knowledge sharing throughout the medicine development lifecycle.
6. Ensure compliance with regulatory standards including GMP, ICH, EMA, and FDA guidelines.
7. Support the preparation of global regulatory submissions, scientific reports, and patents.
8. Develop phase-appropriate quality control strategies for drug substance and drug product.
9. Manage drug substance and drug product stability study programs.
10. Develop scientifically sound and data-driven specifications.
11. Oversee analytical and QC activities at CDMOs and Contract Testing Laboratories, including the review and approval of test records, forms, methods, protocols, and reports.
12. Identify and develop suitable analytical methods for comprehensive characterization of drug substances, drug products, associated impurities, and excipients.
13. Maintain documentation within the quality management system.
14. Experience with various cultures, as CDMOs are global, with potential for global travel.

Director Level:

1. Provide broad CMC support for internal programs from GLP tox through IND clinical programs.
2. Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies.
3. Assist in the preparation and review of CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA.
4. Manage CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies.
5. Develop and execute CMC strategies for early and late phase Drug Substance/Drug Product clinical supplies.
6. Implement processes and controls for regulatory materials, intermediates, and drug substances and products.
7. Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production.
8. Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing.
9. Ensure activities align with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed.
10. Work closely with cross-functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers.
11. Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on internal goals and objectives.

REQUIRED QUALIFICATIONS

1. Master's Degree in a relevant scientific discipline.
2. Prior experience with CMC development in gene therapy is highly desired.
3. Minimum of 10 years of experience in biotech for large and small molecules (Director); minimum of 8 years of experience (Associate Director).
4. Strong process understanding in one or more of the following: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy, or LNP.
5. Experience in managing external CDMOs for DS/DP production.
6. Strong understanding of phase-appropriate analytical development and manufacturing strategies for large and small molecules.
7. Experience with US and EU CMC regulatory expectations, technical transfers, and complex development & manufacturing activities.
8. Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success.
9. Ability to travel both domestically and internationally, as needed.

PREFERRED QUALIFICATIONS

1. Previous experience with CMC development in gene therapy.
2. Previous experience managing CDMOs for outsourced manufacturing.
3. Extensive understanding of cGMP regulations.
4. Previous experience working in small to midsize biotech.
5. Previous experience in CMC development of gene therapy products.
6. Previous experience in small molecule and biologics manufacturing.
7. Previous experience in formulation development for complex products like lipid nanoparticles.
8. Experience with various cultures, as CDMOs are global, with potential for global travel.

BENEFITS

1. Company-paid health/vision/dental benefits.
2. Unlimited vacation and generous sick time.
3. Company-sponsored meals and snacks.
4. Wellness, caregiver, and ergonomics benefits.
5. 401(k) with company matching.

Base Salary Range: $170,000 - $215,000
Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity.