Director, Manufacturing Technology CMC Regulatory SupportPosted: November 10, 2009
Director, Manufacturing Technology CMC Regulatory Support DMS 376503 COMPANY: Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development. Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow. LOCATION: Branchburg, NJ DESCRIPTION: Individual will lead a team that will provide support to the Regulatory Affairs (CMC) Organization. This teams primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA(CMC) group with the compilation of responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. This individual will represent this function on multi-disciplinary project teams. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and keep to the timelines established for the respective filings. Responsibilities Include: Generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigation new drug applications and their respective amendments as well as initial marketing applications along with the required supplements and amendments. Working with the Regulatory Affairs (CMC) Organization to develop a series of standard templates for routine filings. Coordinating the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for all noted filings. Summarizing technical reports and documents to meet the needs of a given template section. Preparing and maintain an up to date project plan for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory (CMC) Affairs organization. Working collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory (CMC) Affairs organization to implement an agreed upon regulatory strategy. Participating as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed. Building and supervising a multi-disciplinary team. Developing an optimized work flow for document creation, review and completion. Assisting manager with the development and maintenance of department budget. EXPERIENCE: Minimum of 15 years Biopharmaceutical or Pharmaceutical Industry experience which should include a minimum of 5 years of regulatory including handling/authoring regulatory documentation or related experience. Credit given toward years of industry experience to those with advanced degrees. A working knowledge of the regulatory requirements for the US, Europe and Japan. A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertise in a technical discipline a plus. Working knowledge of cGMPs as they apply to the Regulatory environment. Strong organizational and project management skills. Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings. Demonstrated supervisory skills. EDUCATION: BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering or related field. An advanced degree a plus. Please refer to job code DMS 376503 when responding to this ad.
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