Mfg. Technologies, Principal CMC Regulatory Support AssociatPosted: November 13, 2009
Mfg. Technologies, Principal CMC Regulatory Support Associate I DMS 376504 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 be a member of an interdisciplinary 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 the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the timelines established for the respective filings. Responsibilities include: 1. Responsible for 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. 2. Using standardized templates prepare the respective technical sections for a given regulatory filing. 3. Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned. 4. Summarize technical reports and documents to meet the needs of a given template section. 5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will required a project plan to be maintained based on the deliverables established by the product project teams and the filing schedule established by the Regulatory (CMC) Affairs organization. 6. As required serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed. 7. Assist manager with the mentoring of the teams less experienced members. 8. Assist manager with the preparation of an optimized work flow for document creation, review and completion. EXPERIENCE: A minimum of 7-10 years Biopharmaceutical or Pharmaceutical Industry experience which should include 1-3years of regulatory Handling/authoring regulatory documentation or related experience. Credit given toward years of industry experience to those with advanced degrees. A working knowledge of US regulatory requirements with global regulatory experience a plus. 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 skills. Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings. EDUCATION: BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering or related field. An advanced degree a plus. Please visit www.discoverysolutions.net for all of our open positions. Please refer to job code DMS 376504 when responding to this ad.
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