Senior Process Development & Manufacturing Leader

Assembly Biosciences, Inc.; South San Francisco (CA); Hybrid; USD 199,000 - 204,000; Full time

Job summary

Assembly Bio is seeking a Senior Manager to lead process development and manufacturing for small molecule drug substances in a hybrid South San Francisco role. You will oversee development, scale‑up, and tech transfers, ensuring cGMP compliance and robust manufacturing strategies across CMOs.

The role requires advanced degree plus substantial hands‑on experience in process chemistry, CRO/CMO interaction, and regulatory support for submissions. Strong collaboration and leadership are essential.

Qualifications

• PhD with 3+ years, MS with 6+ years, or BS with 8+ years of small molecule drug substance development experience.
• Strong hands‑on process chemistry experience and familiarity with drug substance manufacturing equipment.
• Knowledge of global regulatory requirements (cGMP, ICH, USP).
• Experience coordinating CROs/CMOs for drug substance development and testing.

Responsibilities

• Support drug substance development and manufacturing activities at CMOs to ensure timely delivery.
• Collaborate with CMOs to design, develop, and implement robust chemical synthesis processes.
• Support technical transfer of processes between sites as needed.
• Contribute to phase-appropriate route design and control strategy implementation.
• Coordinate with cross-functional teams to align drug substance and drug product programs.
• Provide technical reviews of batch records, deviations, and investigations.
• Design and execute experiments for robustness, scale‑up, transfer, and validation.
• Review regulatory submissions and provide technical justifications for questions.

Skills

Process chemistry expertise

CRO/CMO coordination

cGMP knowledge

Regulatory knowledge (ICH, USP)

Communication & collaboration

Project management

Education

PhD

MS

BS

Job description

Assembly Bio is seeking a Senior Manager to lead process development and manufacturing for small molecule drug substances in a hybrid South San Francisco role. You will oversee development, scale‑up, and tech transfers, ensuring cGMP compliance and robust manufacturing strategies across CMOs.

The role requires advanced degree plus substantial hands‑on experience in process chemistry, CRO/CMO interaction, and regulatory support for submissions. Strong collaboration and leadership are essential.