Manager, Process Support and Quality Control
Iowa City, IA
The Manager, Process Support and Quality Control will provide technical support and leadership for the Process Support and Quality Control laboratory staff. The incumbent will allocate staff resources, assess new project opportunities and manage overall laboratory operation and efficiency.
- Maintain and manage cGMP and general lab systems at defined levels of compliance
- Assign and monitor all QC and Process Support resources and monitor progress for product development, implementation and plant support
- Review and approve work products and technical reports for clarity and accuracy
- Oversee purchase, use and maintenance of analytical instrumentation
- Oversee training and professional development of laboratory staff
- Draft and review various documents in support of laboratory efforts and production campaigns
- Assist with coordination and approval of off-site testing as necessary for operation of Analytical laboratories
- Bachelor's Degree in Chemistry, Pharmacy or closely related field required. Advanced degree highly beneficial and desired.
- 7 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience, with at least 3-5 years in management or supervisory role in pharma industry
- Hands on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.
- Familiarity with compliance requirements within cGMP, safety and regulatory environments
- Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations required
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment