
Senior Quality Chemistry Lead
2 days ago
We are seeking a highly skilled and experienced Quality Control Chemistry Manager to lead our Quality Control (QC) Chemistry Laboratory team in ensuring the highest quality laboratory testing of clean utility, raw material, in-process, and final container materials.
The ideal candidate will have a deep understanding of relevant cGMP regulations, experience with chromatography instrumentation and methods, and excellent communication skills. They will be responsible for managing the QC Chemistry team, ensuring compliance with current Good Manufacturing Practices (cGMP) and safety standards, and maintaining full integrity of laboratory data.
Responsibilities- Manage the Quality Control (QC) Chemistry Laboratory team to carry out required chemistry, immunochemistry, and protein testing.
- Ensure high-quality laboratory testing of clean utility, raw material, in-process, and final container materials, maintaining full compliance with current Good Manufacturing Practices (cGMP) and safety standards.
- Creation, review, and update of test methods and SOPs to ensure all aspects of compliance are adhered to.
- Drive and oversee process/product/OOS/deviation investigations.
- Implementation of Corrective and Preventative Actions.
- Maintain, monitor, and report QC Chemistry metrics and KPIs.
- Ensure training and development of QC Chemistry team members in conjunction with team development and goals via the performance management process.
- Represent QC Chemistry in any regulatory, corporate, or internal audits.
- Ensure regular Quality interaction with other departments within the organization.
- Full understanding of relevant cGMP, quality, and compliance regulations.
- Experience with chromatography instrumentation and methods.
- Experience with protein chemistry instrumentation and methods.
- Method Transfer and qualification experience.
- Understanding of pharmacopoeial requirements and methods.
- Excellent communication skills at organisation, team, and individual levels.
- Demonstrated problem-solving skills.
- Strong decision-making skills.
- Strong presentation skills.
- Ability to manage multiple projects to plan/budget.
- Experience in developing analytical methods is desirable.
- Experience with Statistical Process Control (SPC) is desirable.
- Experience with Lab Management Systems & SAP is desirable.
- BSc or equivalent in chemistry, biochemistry, pharmaceutical science, or related field.
- Minimum 3 years supervisory/management experience.
- 8 years progressive experience as an individual contributor in a fast-paced GMP Laboratory environment.
- M.Sc. qualification is desirable but not essential.
This is a challenging opportunity for a seasoned professional to take on a leadership role and drive excellence in Quality Control Chemistry.
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