Associate Director, Process Development and Manufacturing

Role Summary

We are seeking an Associate Director of Process Development and Manufacturing. This person will be responsible for managing process chemistry activities for Assembly Biosciences’ small molecule compounds, including development of drug substance manufacturing routes, process scale-up, technology transfers and CMO management.

Responsibilities

• Leading drug substance development and manufacturing activities at CMOs to ensure seamless executions of the work packages and delivery of drug substance meeting all quality standards.
• Managing strategic CMOs to design, develop, and implement robust chemical synthesis processes for starting materials, intermediates, and APIs.
• Supporting technical transfer of starting material, intermediates, and API processes between sites as needed.
• Phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials, intermediates, and APIs to support early and late-stage programs.
• Performing fate and purge studies, mutagenic impurity evaluation, and establishing the framework for the control strategy of the drug substance throughout the phases of development.
• Working closely with cross-functional teams to ensure seamless transitions between drug substance and drug product programs and vendors.
• Providing technical leadership in ensuring that CMO manufacturing facilities are compliant with cGMPs.
• Providing technical review and approval for batch records, development protocols, manufacturing deviations and investigations as well as technical reports.
• Defining strategies and designing experiments for process robustness studies and optimization in support of the process scale-up, transfer and validation.
• Providing technical support for manufacturing deviations, OOS/OOT investigations and troubleshooting.
• Reviewing and summarizing process development results and analytical data from CROs/CMOs, conducting trend analysis.
• Authoring and reviewing the drug substance sections of regulatory submission documents. Providing technical justifications to address any regulatory questions.
• Functioning as a highly effective communicator, discussion leader, and team player in a dynamic team culture.

Qualifications

• PhD with 6+ years’ experience or MS with 8+ years’ or BS degree with 10+ years’ experience of small molecule drug substance development experience in pharmaceutical or biotech industry.
• Strong technical skills in process development and manufacturing.
• Must have hands-on experience working in process chemistry along with in-depth knowledge on drug substance manufacturing equipment.
• Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH, USP)
• Experience working with contract organizations for drug substance development, manufacturing and testing.
• Effective communication, interpersonal skills, collaboration and time management skills.
• Self-motivated, comfortable in fast-paced small company environment. Able to manage multiple projects simultaneously and adjust to changing program priorities.