Senior Director, Biologics Process Development

PURPOSE OF JOB:   

The Senior Director, Biologics Process Development is responsible for leading a group of process scientists. 

• Responsible for the process development and supply of monoclonal antibody drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities.


• Managing all GMP aspects of the development projects carried out entirely by outsourcing to various contract research or manufacturing organizations (CRO/CMO).


• Mentoring scientists and direct experiments conducted in-house to optimize the downstream purification process of late-stage API.

MAJOR DUTIES AND RESPONSIBILITIES:

• Develop overall drug substance process development strategy, timelines, budgets, risks & mitigations plans of all process development and manufacturing campaigns.


• Execute on manufacturing technology transfer, supply chain strategy for late stage (Phase 2 through NDA stage) clinical supply.


• Lead process improvement and clinical batch manufacturing for a late-stage monoclonal antibody project at the CMO.


• Actively manage development activities including scale up and technology transfer at the CMO.


• Author or review and approve process validation strategies, protocols and reports.


• Develop a control strategy and perform modeling to assess process parameter criticality, develop process acceptance ranges, operating ranges, and documents in preparation of the validation campaign.


• Collaboratively work with multiple groups within the organization to support the development of the API supply chain in preparation for the BLA and commercial launch.


• Select CMOs for project-specific activities.


• Identify key process parameters and relevant in-process controls.


• Working with Analytical Development, be accountable for comparability studies to facilitate implementation of process changes across manufacturing sites.


• Derive origins of process impurities and steps for their control, mechanistic studies of reactions when needed, and actively work with contract research organizations on preparation of process impurities.


• Represent Biologics Process Development at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects.


• Lead the authorship and review of Module 3 process CMC sections to support regulatory (IND, IMPD, BLA) submissions.


• Serve as a subject matter expert and provide technical expertise to evaluate process-related deviations and manufacturing challenges.


• Review and approve batch documents for drug substance manufacturing.


• Maintain process trend data to understand process changes.


• Work with project teams to identify drug substance requirements, managing and optimizing aggressive project timelines, overseeing the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered.

EDUCATION REQUIREMENTS: 

• PhD in chemical engineering, biochemical engineering, biochemistry, or appropriate technical discipline with 15+ years (MS with 15+ years) of industrial bioprocess development experience.

EXPERIENCE REQUIREMENTS: 

• Must have a minimum of 10 years managerial experience.


• Late-stage development (validation) experience of biologics drug substance is required.


• Experience handling technology transfer and technical support including OOS, deviations, and troubleshooting of drug substance manufacturing processes.


• Extensive experience collaborating with and overseeing CMOs and third-party manufacturers.


• Demonstrated experience with track record of success leading technical teams, experience in process scale-up and development of scale-down models.


• Must-have advanced knowledge of DOE principles, process characterization, and BLA submission.


• Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.


• Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines.


• Strong background and subject matter expertise in upstream and purification unit operations including column chromatography, filtration (TFF), harvest and viral clearance validation.


• Broad knowledge of regulatory (ICH) and cGMP requirements for pharmaceutical products.

OTHER QUALIFICATIONS:  

• Possess advanced biologics process development skills combined with exceptional project leadership, organization, and communication skills.


• Ability to communicate effectively and connect with all levels of the organization.


• Strong project leadership and resource management skills.


• Require excellent written/oral communication.


• Travel up to 25%.