Senior Director, Process Chemistry

PURPOSE OF JOB:

The Senior

Director, Process Chemistry leads the process scientists and is responsible for the process development and supply of small molecule drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities. All GMP aspects of the development projects are carried out entirely by outsourcing to various contract research or manufacturing organizations (CRO/CMO). You will be required to mentor scientists and direct experiments conducted in-house to optimize the synthetic routes and the manufacturing processes of various APIs in the pipeline.

MAJOR DUTIES AND RESPONSIBILITIES:

• Develop overall API strategy, timelines, budgets, risks & mitigations plans of all process development, starting materials, and manufacturing campaigns
• Execute on supply chain strategy for late stage (Phase 2 through NDA stage) clinical supply
• Lead process improvement and clinical batch manufacturing for various early to late-stage API projects at the CMO
• Manage development activities including scale up and technology transfer at the CMO
• Develop a control strategy, process acceptance ranges, operating ranges, and documents in preparation of the validation campaign
• Collaborate with multiple groups within the organization to support the development of the API supply chain in preparation for the NDA and commercial launch
• Select CMOs for project-specific activities
• Work with contract research organizations to optimize the crystallization process for the last synthetic step of the API
• Identify source for starting materials and intermediates, and develop plans for consistent and continuous supply
• Identify key process parameters and relevant in-process controls
• Derive origins of process impurities and steps for their control, mechanistic studies of reactions when needed, and actively work with contract research organizations on synthesis or isolation of process impurities
• Represent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
• Lead the authorship of appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions
• Act as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues
• Review and approve batch documents for drug substance manufacturing
• Maintain process trend data to understand process changes
• Interact with outside patent counsel in helping to draft patent applications for any new chemistry
• Work with project teams to identify drug substance requirements, manage and optimize aggressive project timelines, oversee the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered
• Other duties as assigned
• Travel: Up to 20%

EDUCATION REQUIREMENTS:

• PhD, Organic Chemistry or Chemical Engineering

EXPERIENCE REQUIREMENTS:

• Pharma/biotech industry experience in pharmaceutical process development and drug substance manufacturing preferably at a commercial level for small molecules (minimum 15 years with an MS, 10 years with a PhD)
• Advanced pharmaceutical organic chemistry skills combined with exceptional project leadership, organization, and communication skills.
• A minimum of 3 years' experience in supervising direct reports

OTHER QUALIFICATIONS:

• Ability to work independently in a fast-paced environment
• Thorough knowledge of process chemistry and scale-up with a proven track record in developing and implementing robust and efficient drug substance manufacturing processes
• 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
• Experience handling process capability studies to support process validation in drug substance manufacturing
• Ability to validate late-stage or commercial manufacturing drug substance processes and a proven track record in cGMP manufacturing
• Broad knowledge of regulatory (ICH) and cGMP requirements for pharmaceutical products
• Experience reviewing and/or authoring CMC section for regulatory submissions
• Exceptional communication, collaboration, and problem-solving skills ensuring alignment with other functions

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally.
• Visual Acuity - Perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.