Title: QC Manager
Summary:
Our client is a leading global CDMO that offers services related to drug substance, drug product, and drug product lifecycle. They offer their clients and customers end-to-end collaboration for the design, production, and R&D of small molecule treatments at every stage of the lifecycle. At every stage of the lifecycle, they provide end-to-end collaboration to their clients and customers for the design, manufacture, and R&D of small molecule medicines. The QC Manager is responsible for the day-to-day operations of the isolated intermediates and finished goods testing subgroup of QC and will report to the Director of Process Support and Quality Control, oversees the subgroup's immediate daily operations.
Responsibilities:
- Produce SOPs, analytical techniques, reports, and specifications as necessary and approve, update, or evaluate them.
- Participate in interdepartmental project meetings, inquiries, and facilities audits as a department representative for internal and external clients.
- Work with QC Supervision and the QC Planner to prioritize daily QC testing, including staff and equipment use.
- Examine and accept methodology and technical reports for their accuracy and clarity.
- Carry out your own significant laboratory investigations for crucial operational PRs that might have an impact on commercial or regulatory items.
Qualifications:
- Bachelor's Degree in Chemistry, Pharmacy or closely related field required.
- Advanced degree highly beneficial.
- 7 or more years of experience in manufacturing support laboratory in the pharmaceutical 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
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment
Benefits:
- Medical
- Dental
- Vision
- Relocation assistance
- 401K Matching
- Company vacations
- Option for remote after 6 months
