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Senior Director Process Chemistry
4 months ago
Senior Director, Process Chemistry
Technical Operations
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 campaignsExecute on supply chain strategy for late stage (Phase 2 through NDA stage) clinical supplyLead process improvement and clinical batch manufacturing for various early to late-stage API projects at the CMOManage development activities including scale up and technology transfer at the CMODevelop a control strategy, process acceptance ranges, operating ranges, and documents in preparation of the validation campaignCollaborate with multiple groups within the organization to support the development of the API supply chain in preparation for the NDA and commercial launchSelect CMOs for project-specific activitiesWork with contract research organizations to optimize the crystallization process for the last synthetic step of the APIIdentify source for starting materials and intermediates, and develop plans for consistent and continuous supplyIdentify key process parameters and relevant in-process controlsDerive 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 impuritiesRepresent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding programLead the authorship of appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissionsAct as the technical subject matter expert (SME) internally for troubleshooting process chemistry issuesReview and approve batch documents for drug substance manufacturingMaintain process trend data to understand process changesInteract with outside patent counsel in helping to draft patent applications for any new chemistryWork 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 deliveredOther duties as assignedTravel: Up to 20% EDUCATION REQUIREMENTSPhD, Organic Chemistry or Chemical EngineeringEXPERIENCE REQUIREMENTSPharma/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 reportsOTHER QUALIFICATIONSAbility to work independently in a fast-paced environmentThorough knowledge of process chemistry and scale-up with a proven track record in developing and implementing robust and efficient drug substance manufacturing processesExperience handling technology transfer and technical support including OOS, deviations, and troubleshooting of drug substance manufacturing processesExtensive experience collaborating with and overseeing CMOs and third-party manufacturersExperience handling process capability studies to support process validation in drug substance manufacturingAbility to validate late-stage or commercial manufacturing drug substance processes and a proven track record in cGMP manufacturingBroad knowledge of regulatory (ICH) and cGMP requirements for pharmaceutical productsExperience reviewing and/or authoring CMC section for regulatory submissionsExceptional communication, collaboration, and problem-solving skills ensuring alignment with other functionsPHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONSPhysical 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.