Senior Manager, Process Development and Manufacturing

About the role

Assembly Bio is hiring a Senior Manager, Process Development and Manufacturing in South San Francisco, California, reporting to the Executive Director of Process Development and Manufacturing. The role supports process chemistry activities for small molecule compounds, including drug substance manufacturing routes, process scale-up, technology transfers and CMO coordination. It is a regular, full-time, exempt position with a hybrid arrangement.

Key responsibilities

• Support drug substance development and manufacturing at CMOs so that drug substance is delivered on time and meets quality standards.
• Work with CMOs to design, develop and implement robust chemical synthesis processes for starting materials, intermediates and APIs.
• Support technical transfer of starting material, intermediate and API processes between sites.
• Contribute to phase-appropriate synthetic route design and control strategies, including fate and purge studies and mutagenic impurity evaluation.
• Ensure smooth transitions between drug substance and drug product programs and CMOs.
• Help ensure CMO manufacturing facilities are compliant with cGMPs.
• Review and approve batch records, deviations, investigations and technical reports.
• Design and run experiments for process robustness, optimization, scale-up, transfer and validation.
• Summarize process development results and analytical data from CROs/CMOs.
• Support writing and reviewing drug substance sections in regulatory submissions, including technical justifications.

Required profile

• Ph.D. with 3+ years, MS with 6+ years, or BS with 8+ years of small molecule drug substance development experience in pharma or biotech.
• Experience working with CROs/CMOs for drug substance development, manufacturing and testing.
• Effective communicator with strong collaboration and time-management skills, able to manage multiple projects in a fast-paced environment.

Required skills

• Process chemistry and hands-on experience with drug substance manufacturing equipment.
• Knowledge of global regulatory requirements such as cGMP, ICH and USP.