Senior Manager, Process Development and Manufacturing

Assembly Biosciences, Inc.•South San Francisco, CA

6d•$199,400 - $203,700•Hybrid

About The Position

The Senior Manager of Process Development and Manufacturing will be responsible for supporting process chemistry activities for Assembly Biosciences’ small molecule compounds, including development of drug substance manufacturing routes, process scale-up, technology transfers and CMO coordination. This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Requirements

Ph.D. with 3+ years, MS with 6+ years, or BS with 8+ years of small molecule drug substance development experience in the pharmaceutical or biotech industry.
Strong technical skills and hands-on experience in process chemistry, including in-depth knowledge of drug substance manufacturing equipment.
Knowledge of global pharmaceutical regulatory requirements (e.g., cGMP, ICH, USP).
Experience working with CROs/CMOs for drug substance development, manufacturing, and testing.
Effective communicator with strong interpersonal, collaboration, and time-management skills.
Self-motivated and adaptable in a fast-paced environment, able to manage multiple projects and shifting priorities.

Responsibilities

Supporting drug substance development and manufacturing activities at CMOs to ensure timely delivery of drug substance meeting quality standards.
Collaborating with 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.
Contributing to phase-appropriate synthetic route design and control strategy implementation (including fate and purge studies and mutagenic impurity evaluation) for starting materials, intermediates, and APIs across early- and late-stage programs.
Collaborating cross-functionally to ensure seamless transitions between drug substance and drug product programs and CMOs.
Providing technical support in ensuring that CMO manufacturing facilities are compliant with cGMPs.
Providing technical review and approval of batch records, deviations, investigations, and technical reports.
Designing and executing experiments for process robustness, optimization, scale-up, transfer, and validation.
Reviewing and summarizing process development results and analytical data from CROs/CMOs.
Supporting authoring and reviewing drug substance sections in regulatory submissions, including technical justifications for regulatory questions.
Functioning as a highly effective communicator, discussion leader, and team player in a dynamic team culture.