FierceBiotech and FiercePharma Jobs
Stability Manager - Covance
Nov 10
Location: Greenfield, INCategories: All Categories
Website: http://www.covancecareers.com
Position Description
Stability Manager
Greenfield, IN
Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world’s premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services supporting the development and manufacture of biotechnology, biopharmaceutical and vaccine products.
We are currently seeking a Stability Manager for our biotechnology lab in Greenfield IN. As the manager you will:
• Provide technical and managerial leadership to the stability team
• Manage the design and implementation of stability studies
• Meet with clients on site and at their sites as necessary to support their needs and determine the appropriate resolution of client issues
• Responsible for the regulatory compliance of all functions within their scope
• Guide direct reports, internal clients and less experienced peers in GLP and cGMP interpretation
• Write SOPs supporting Quality systems, data systems, technical issues and instrumentation
• Write and support the writing of study proposals and reports that are sent to a company sponsor or Regulatory agencies
Qualifications include:
• Bachelor of Science/Arts (BS/BA) degree
• 8-15 years of experience in the biotechnology, biopharmaceutical or pharmaceutical industry
• 3+ years of supervisory and/or managerial experience in a regulated portion of the biotechnology or biopharmaceutical industry
• Expert working knowledge of Stability programs and associated Regulatory requirement
pertaining to Biologics
• Prior experience designing stability programs for a biopharmaceutical or biotechnology company
• Expertise in the interpretation of analytical data supporting stability studies
• Functional knowledge of LIMS and other electronic data systems
• Strong knowledge of GMP and GLP requirements and ICH and FDA guidelines in relation to stability
• Strong technical writing skills
• Ideal candidate would have run stability programs in support of biologics
At Covance, you can make a difference, not only by helping to deliver life-saving and life-enhancing medicines to people around the world, but also by helping us become a great company. We are committed to delighting our clients with the broadest and best service portfolio in our industry. This ever-changing environment energizes our people and offers exceptional growth opportunities.
