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WHAT
IN
Director Manufacturing Technology CMC Regulatory
Job
KFORCE Professional Staffing
US
-
Bridgewater,
New Jersey
Job Code - 950550-NRC
Position - Direct Hire
Job First Active on: Tuesday, November 03, 2009
APPLY TO THIS JOB (You will be applying directly to KFORCE Professional Staffing for this position!)
JOB DESCRIPTION: Director, Manufacturing Technology CMC Regulatory
At Kforce Clinical Research, we don't just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Manufacturing Technology CMC Regulatory Director in Bridgewater, NJ. The Director will be responsible for leading a team that will provide support to the Regulatory Affairs Organization. Specific Accountabilities:
* Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC)
* Organize all noted filings
* Summarize technical reports and documents to meet the needs of a given template section
* Prepare 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)
* Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory (CMC) Affairs organization to implement an agreed upon regulatory strategy
* Participate as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed
* Build and supervise a multi-disciplinary team
* Develop an optimized work flow for document creation, review, and completion
* Assist manager with the development and maintenance of department budget
REQUIREMENTS - QUALIFICATIONS: Director, Manufacturing Technology CMC Regulatory
For you to be the successful candidate we are looking for in this role you must have a minimum of 15 years of Biopharmaceutical or Pharmaceutical industry experience which should include a minimum of 5 years of regulatory including handling/authoring regulatory documentation or related experience. Credit is given toward years of industry experience to those with advanced degrees. You will also need:
* Working knowledge of the regulatory requirements for the US, Europe, and Japan
* Working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing; expertise in a technical discipline is a plus
* BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering, or related field; an advanced degree is 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
Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!
KFORCE Professional Staffing
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