QC Technical Manager
QC Technical Manager
The candidate is expected to oversee the technical agenda for the QC laboratory which involves testing of raw materials, in process samples, drug substance and drug product samples. The candidate is expected to oversee the technical training of analysts to ensure operational excellence as well as leading troubleshooting activities in the QC laboratory. The successful candidate will work closely with the QC analytical technology group to ensure successful lifecycle application to analytical methods and expected to support regulatory filings as well as inspections. The successful candidate will have a strong analytical background, ideally with experience in biopharmaceutical quality control. Essential to this role is method validation knowledge and the ability to technically lead and mentor laboratory staff.
This position offers significant opportunity to develop scientific skills in a biotechnology environment. The selected candidate will work in a creative, fast-paced environment, interacting with scientists or individuals from diverse backgrounds. The candidate will be required to provide scientific expertise, monitor technical excellence and identify areas for improvement in the QC laboratory. The candidate will drive the QC technical agenda and will monitor method performance through trending tools. It is especially important that there is both willingness and ability to ensure group-wide compliance with current regulatory requirements (cGMP) for testing of manufactured pharmaceutical products and intermediates.
- Ensure technical training consistency and streamlining.
- Train department staff on testing and laboratory systems
- Identify areas for improvement and drive opportunities for same.
- Work closely with QC analytical technology colleagues to identify and implement method lifecycle opportunities in the QC operations teams.
- Ensure laboratory readiness for validation activities and testing.
- Prepare technical reports and summaries
- Prepare final reports, study plans, etc., as necessary for multiple projects
- Prepare and deliver presentations of experimental results in internal forums
- Contribute to project progress within his/her scientific discipline
- Support regulatory filings and agency inspections.
- Biochemistry/Analytical chemistry educational background.
- 10+ years experience in a QC environment with a demonstrated track record of technical excellence.
- High level of initiative, independence, and ability to work under short time lines with limited day to day supervision.
- Expertise in HPLC and related software. Preferential experience in additional analytical techniques such as CE, FTIR, Protein determination, plate based assays.
- Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or Minitab).
- Familiarity with a range of analytical technologies such as HPLC, ELISA.
- Good written and verbal skills.
- Strong critical thinking/problem solving skills.