Director Formulations Development CMC
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POST DATE 9/10/2016
END DATE 10/8/2016
Omega Management Group
JOB DESCRIPTIONJob Title: Director, Formulation Development (CMC)
Responsible for oversight and direction of CMC activities for new product development programs (eg, NMEs, line extensions, in-licensed opportunities, etc). Provide technical leadership and CMC expertise in support of the company s program goals. Develop and direct strategies for preformulation and formulation development, analytical development, and API manufacturing process development (including management of associated external CMOs/CROs). Provide CMC and technical leadership regarding global regulatory submissions. Direct the CMC program budget as needed to maintain the company s CMC development programs on schedule.
Direct CMC activities associated with the company s global programs. Work closely with external CROs/CMOs, collaborators, and/or partners to rapidly advance programs to key decisions.
Contribute technical CMC expertise in support of the company s due diligence and life cycle management activities. Partner with Business Development function, internal CMC evaluation team, and external experts/consultants to critically evaluate and select in-licensing and partnering opportunities related to potential new development programs.
Develop and direct strategies for preformulation, formulation, analytical, and process development (including management of associated external CMOs/CROs). Partner with Project Management, Preclinical, Clinical, and Regulatory functions (typically as part of cross-functional project teams) to ensure that project development timelines are in place and aligned with the project s overall objectives.
Provide CMC and technical leadership for company s global regulatory submissions (INDs, IMPDs, NDAs, BLAs, MAAs, Meeting Requests, Briefing Documents, Responses to Health Authority questions, etc) related to assigned programs. Partner with Project Management, CMC Writing, and Regulatory functions to ensure submission timelines are established and maintained. Collaborate with external experts/consultants to ensure submission content is aligned with current Health Authority requirements/ expectations.
Proactively collaborate with QA, Technical Services, and Manufacturing to efficiently evaluate, select, and manage contract service providers (CMOs and CROs); scale-up and transfer technology; design validation strategies; and provide technical expertise with regards to routine and nonroutine cGMP activities (eg, deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc).
Oversee the development and maintenance of CMC budget for assigned global pharmaceutical sciences program activities, including the preparation of cost estimates for new work. Track invoice approvals and proactively verify versus work performed. Partner with Finance and Project Management to periodically review and report on the status of project spend versus the approved budget. Recommend appropriate budgetary adjustments in conjunction with changing project scope and timelines.
Develop and/or provide critical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc). Support the creation, maintenance, improvement, and routine use of Quality Systems. Contribute to the generation and protection of company intellectual property.