Senior Manager, Biologics Drug Substance (Upstream)

Responsibilities 
 
The Senior Manager, Biologics Drug Substance is responsible for mid-late stage biologic products development, including developing, optimizing and scaling up downstream or up stream bioprocesses for the commercial production of biologics, ensuring the robustness, scalability, and compliance of downstream or upstream operations. 

Job Description 

• Manage the technical aspects of downstream or upstream process optimization, scale up and technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. 

• Support process characterization (PC) and process validation activities (PPQ) for downstream processes executed at CDMOs. 

• Oversee the downstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. 

• Act as the technical lead for trouble shooting of downstream process deviations or performance issues at CDMOs, including determination of product or process impact, root-cause analysis, and corrective action identification. 

• Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility. 

Qualifications 

• A degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience working in an cGMP regulated environment.  

• Bachelor’s degree with 10+ years of work experience, or Master’s degree with 7+ years of work experience, or PhD degree with 5+ years of work experience.  

• For downstream: Experience with downstream purification process development, process characterization and validation 

• For upstream: Experience with cell line development, cell culture process development, cell culture process characterization and validation. 

• Experience of performing processes technical transfer and scale-up. 

• Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards.