GMP QC Lab Manager, Berg Pharma, Nashville, TN
Berg Pharma is seeking a cGMP Quality Control Lab Manager to join our exciting team in Nashville, TN. Quality Control Lab is responsible for testing intermediate, final and stability product samples to demonstrate that all products meet all standards required for cGMP operations. The QC Lab Manager will lead the QC Lab to support all analytical needs and ensure cGMP compliance. In addition, this role will own and review quality records, processes and documents, including method development, method validation, CAPAs, Change Controls and SOPs.
- Manage QC Lab, method validation, equipment and data systems
- Create, revise, review and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of GMP starting materials, intermediates, and APIs.
- Demonstrate technical proficiency in analytical methodology and adherence to cGMP and ICH compliance.
- Review and approve Certificate of Analysis, Certificate of Test, and stability studies
- Serve as QC lead on analytical projects teams and product operational teams.
- Collaborate with regulatory to support IND filling/amendments on CMC section.
- Evaluate resource requirements to support projects and assure projects remain within budget.
- Train direct reports on QC job related functions and technical methods.
- Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan.
- Perform other duties as may be required or necessary
- BS or MS in Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent with 10-15 years of relevant experience in QC or equivalent experience in the pharmaceutical industry.
- 5 to 10 years of relevant GMP QC laboratory experience and 5 years in a supervisory role, particularly in a GMP environment.
- Experience in a pharmaceutical manufacturing environment.
- Expertise in analytical method development, analytical method validation, and statistical quality control.
- Excellent knowledge of cGMP, ICH, USP and global compedial regulations and guidance's, particularly as related to analytical method development and validation.
- Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports
- Strong leadership skills.
- Able to interact, cooperate, and motivate across departments and functions.
- Work in a fast paced pharmaceutical environment, able to work flexible schedules on a short quick notice.
In order to be considered for this position, please send your resume, cover letter, and references to firstname.lastname@example.org.
Berg Pharma focuses our research on understanding how alterations in metabolism relate to disease onset. The company has a deep pipeline of early-stage technologies in CNS diseases and metabolic diseases that complement its late-stage clinical trial activity in cancer and prevention of chemotoxicity. Armed with use of the Interrogative Biology® discovery platform that translates biological output into viable therapeutics and a robust biomarker library, Berg Pharma is poised to realize its pursuit of a healthier tomorrow.