|
|
|
|
|
|
|
|
|
|
|
|
Novartis Pharmaceuticals Corporation
Biopharmaceutical Mfg Microbial Fermentation Expert - Vacaville, CA -- 57381BR
Location: Vacaville,
California
95687
Posted on:
10/4/2009 8:39:46 PM
Postion type:
Full time
Job Code:
1705304HHL
Required Education:
Doctorate
Salary:
DESCRIPTION
Novartis is dedicated to providing healthcare solutions that address the evolving needs of patients and societies worldwide. Our focus is on patients: We provide innovative products to treat and prevent diseases, expand access to critical medicines, ease suffering and improve quality of life. Our Vacaville facility was established in 1994 by Chiron Corporation and was acquired by Novartis in 2006. As a result of significant investments in both capital and human resources over the three years, it is a Novartis Center of Excellence for the clinical commercial production of biopharmaceuticals by microbial fermentation, designed to support the manufacture of Novartis’ growing pipeline of products to address serious medical needs.
The Microbial Fermentation Expert will:
•Deliver state-of-the art know-how to process unit in terms of microbial fermentation, both bacterial and yeast
•Must have an expert level of knowledge in global pharmaceutical cGMP's and must be able to develop solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovativeness.
•Provide employees with training and resources to meet or exceed customer requirements
•Acts as SPOC in scientific questions
•Monitor processes and products to identify opportunities for continuous improvement
Major accountabilities include:
•Create a “Center of Excellence” for microbial fermentation within the company
•Develop, run and improve large-scale microbial fermentation
•Support product release including investigations for process exceptions, technical assessment of issues, root cause investigations and CAPA
•Develop and manage the staffing necessary to support the above responsibilities.
•Owner of process improvement plan including maintaining process data, trending, cycle time im-provement projects, yield improvement projects and change control tech review
•Technical lead for new products to site including new product feasibility assessments, process and equipment requirements, process validation technical review.
•Active participation in health authority audits (FDA, EMEA)
•Support regulatory compliance through CMC document preparation and review and technical support for regulatory inspections
•Support Global Biopharmaceutical initiatives through technical support for business feasibility studies, project teams and due diligence teams
•Provide project management leadership to ensure key initiatives are well understood and effectively deployed
•Support site as key member of the senior leadership team
REQUIREMENTS:
-PhD in Microbiology, Biochemistry, Biochemical/Chemical Engineering
-English required; German or French desirable
-Minimum of 5 years in a commercial manufacturing environment
|
|
 |
|
|
|
|
|
|
|
|
|