•Lead a high performing technical team of PhD and non-PhD process and analytical chemists, formulations scientists, and supply chain specialists
•Provide oversight and direction for individuals and teams responsible for CMC process development and manufacturing for all clinical programs Create, promote and improve team technical capabilities and workflows
•Provide proactive leadership and scientific expertise in developing and applying new approaches in solving complex technical problems
•Organize and leverage resources to maximize output and successfully develop Karyopharm programs with a small core internal team
•Provides guidance, mentoring, and development of staff; ensures team has appropriate skills, capabilities, and resources to meet current and future scientific and/or business needs.
•Build and maintains strong working relationships with relevant internal and external customers and partners; ensuring that activities are managed collaboratively, efficiently and effectively
•Provide strategic guidance for cross-functional plans, coordinating non-clinical, clinical and CMC activity
•Provide scientific guidance, risk assessments, and oversight while factoring in technical, quality, regulatory, and intellectual property considerations
•Meet with the executive leadership team and business partners to ensure CMC deliverables and requirements are synergized with strategic product development plans and Karyopharm development strategies
•Provide strong strategic thinking and leadership while responding to data in rapidly changing environments
•Ensures all development, manufacturing, and process validation activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.Responsible for core CMC regulatory strategies, synergizing CMC regulatory filings with corporate and project goals, and drafting answers questions from regulatory authorities.
•Responsible for the proper resourcing of all department scientific and CMC regulatory deliverables for clinical trial and marketing applications
•Reviews and edits CMC sections of regulatory submissions and regulatory approvals (e.g., IND, CTA, NDA, and MAA) with overall responsibility/accountability for the technical content of Module 3 of the Common Technical Document.
•Lead the continued development of CMC workflows and standard operating procedures and ensure adherence to them. Ensures the department complies with protocols and the departments Standard Operating Procedures.
•Review, edit, and strategize for the writing of process patents, position papers, and scientific articles relating to CMC pharmaceutical development.
•Reviews Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of the activities.
•Promote and reinforce Karyopharm’s ICURE values
•A Doctorate (PhD) in one of the following areas: Pharmaceutical Sciences, Chemical Engineering, Organic Chemistry, Formulations or a related scientific discipline
•At least 15 years of CMC development experience (formulations, analytical and/or process chemistry) in pharmaceuticals
•At least 12 years of relevant manufacturing and process development experience within or pharmaceutical organizations, with a strong preference for emerging pharma
•At least 10 years of management experience in pharmaceuticals.
•Strong understanding and ability to manage all areas of Pharmaceutical CMC development: Process Chemistry, Formulations, Analytical development and Supply Chain.
•Experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters and a demonstrated knowledge, experience, and successful track record CMC regulatory filings (e.g. IND, IMPD and/or NDA).
•Demonstrated knowledge of cGMP aspects of pharmaceutical development
•Established knowledge of applicable global regulatory requirements
•Excellent CMO and vendor management skills with demonstrated experience in vendor manufacturing, validation, process development and/or transfers.
•Demonstrated ability to develop strategies and tactics in pharmaceutical development
•A strong background in oncology drug development experience is preferred.
•New Drug Application (NDA)
Level of education
Doctor of Philosophy
Tagged as: Executive Director, Pharmaceutical Development and CMC
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