Associate Director, CMC Drug Product Manufacturing

About the Role >>> Associate Director, CMC Drug Product Manufacturing

As the Associate Director, CMC Drug Product Manufacturing reporting to the Sr Director, Drug Product Development and Manufacturing, you will provide technical leadership and hands-on execution to support late-stage development, technology transfer to CDMOs, and commercial readiness including NDA filing for small molecule drug product. This role is critical to ensuring successful scale-up, validation, and regulatory approval of drug product processes. The individual will work cross-functionally and externally with CDMOs to deliver robust, compliant, and efficient manufacturing processes suitable for commercial supply.

This role is based out of our Dublin, Ireland office and will require 10-15% travel.

Your work will primarily encompass: 

• Lead preclinical and early clinical phase formulation development effort at CMO and provide oversight of tech transfer to GMP vendor for clinical drug product manufacture and scale up 
• Design and provide oversight of development and characterization studies in evaluating formulation development and drug product unit process feasibility 
• Work closely with CMOs to address and refine formulation and process related challenges over the entire course of product development 
• Develop strategies and execution plans for drug product development from first time in human through development of NDA ready formulations in accordance with timelines and requirements of program strategy 
• Partner with clinical supply team to ensure uninterrupted drug product supply for ongoing studies and risk-mitigate strategically any supply constraints 
• Work closely with project management for alignment on study timeline and corresponding drug product supply plan in terms of adequately securing GMP production slots at CDMOs 
• Work closely with project management to identify critical CMC decision points, gain alignment at Program Team (PT) level and final endorsement from Executive Commitment (EC)  
• Work closely with regulatory CMC team (or consultants) to align on filing strategies from the perspective of being able to provide drug product for studies by clearing regulatory responsibilities  
• Engage in identifying high quality drug product manufacture CMOs or CDMOs in expertise, capability and capacity for effective collaboration in developing and/or commercializing Olema molecule 
• Lead formulation and process development, technology transfer, clinical manufacturing activities & scale-up at CMOs or CDMOs 
• Review and approve manufacturing documents, protocols and reports 
• Support manufacturing and quality function in solving technical issues and addressing deviation investigations 
• Support the design of experiments (DoE) studies to evaluate formulations and process parameter at CDMOs to support NDA filing 
• Support the late-stage process development and optimization activities to identity CPPs, CQAs etc. leading to process performance qualification and commercialization  
• Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development 
• Lead packaging validation, shipping validation & transportation studies at drug product CDMOs in preparation for Olema drug product commercialization 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge & Experience 

• Ph.D. / M.S in Pharmaceutical Science, Chemical Engineering or related field 
• 8+ years' experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5+ years in managing outsourced development activities 
• Experience in formulation and process development; preferably with direct experience with late-stage oral solid dose manufacturing process 
• Good working knowledge of GMP requirements for drug product development and manufacturing 
• Good understanding of ICH, FDA, EMA guidance's in CMC and Quality areas 
• Effective written, oral communication and interpersonal skills 
• Experience in leading formulation projects in pre-formulation, formulation development, process selection and scale up, and oversight of GMP manufacture 
• Experience in leading packaging validation, shipping validation and& transportation studies  
• Be self-motivated, organized, detail-oriented, team-oriented, & problem-solving oriented 
• Being proactive, strategic and skillful in multi-tasking 
• Excel in team settings with ability to think critically, outside of box for problem-solving and work independently 

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