Director, CMC Drug Substance (Biologics/ADCs)

ADARx Pharmaceuticals Inc.; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Equity-based compensation

Performance-based bonuses

401(k) with Company Match

Flexible Spending Account

Life Insurance

Employee Assistance Program

Employee Discounts

Paid Vacation

Paid Holidays

Paid Sick, Jury Duty, Bereavement

Job summary

ADARx Pharmaceuticals, Inc. is seeking a Director of CMC-Drug Substance to lead CMC activities for biologics-related DS programs. The role focuses on developing strategies, managing CDMOs, and ensuring GMP compliance to support IND through late-stage development.

You will collaborate with Regulatory, Quality, Clinical, and Supply Chain teams, driving timelines, budgets, and risk mitigation in a fast-paced, on-site environment at our San Diego site.

Qualifications

• Master’s or PhD in Chemical Engineering, Biochemistry, Biotechnology, or related field strongly preferred.
• 12+ years or BS with 15+ years of biotech/pharmaceutical experience.
• Significant experience in CMC development for biologics, ADCs, AOCs, or siRNAs.
• Demonstrated success overseeing manufacturing at CDMOs.
• Experience supporting IND through late-stage development (BLA experience strongly preferred).
• Strong understanding of upstream/downstream biologics manufacturing processes.

Responsibilities

• Develop and execute integrated CMC strategies for drug substance across all phases of development through commercialization.
• Lead DS-related activities for regulatory filings (IND, CTA, BLA/MAA), ensuring alignment with global regulatory expectations.
• Oversee drug substance manufacturing activities for DS and manage CDMOs to meet timelines and budgets.
• Drive process scale-up, process characterization, and validation strategies.
• Ensure manufacturing readiness for clinical and commercial supply; collaborate with QA and Regulatory.

Skills

CMC development

CDMO manufacturing

IND/BLA experience

Biologics manufacturing

Regulatory interactions

Monoclonal antibodies

RNA therapeutics

Cross-functional collaboration

Education

Master's or PhD in Chemical Engineering/Biochemistry/Biotechnology

Job description

ADARx Pharmaceuticals, Inc. is seeking a Director of CMC-Drug Substance to lead CMC activities for biologics-related DS programs. The role focuses on developing strategies, managing CDMOs, and ensuring GMP compliance to support IND through late-stage development.

You will collaborate with Regulatory, Quality, Clinical, and Supply Chain teams, driving timelines, budgets, and risk mitigation in a fast-paced, on-site environment at our San Diego site.