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:

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

Director Level:

• Provide broad CMC support for internal programs from GLP tox through IND clinical programs.
• Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies.
• Assist in the preparation and review of CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA.
• Manage CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies.
• Develop and execute CMC strategies for early and late phase Drug Substance/Drug Product clinical supplies.
• Implement processes and controls for regulatory materials, intermediates, and drug substances and products.
• Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production.
• Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing.
• Ensure activities align with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed.
• Work closely with cross-functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers.
• 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

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

PREFERRED QUALIFICATIONS

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

BENEFITS

• Company-paid health/vision/dental benefits.
• Unlimited vacation and generous sick time.
• Company-sponsored meals and snacks.
• Wellness, caregiver, and ergonomics benefits.
• 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.