Quality Control Manager
- Provide leadership to 40+ chemist strong laboratory at #1 small molecule API Contract Manufacturing Organization (CMO) in the USA.
- Drive operational excellence initiatives and mindset in daily operation of the facility.
- 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 experiencee 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