Technical Lead Raw Materials
The Technical Lead will provide technical expertise and oversight to the QC Raw Materials Testing group.
Key Duties and Responsibilities:
- Develop and maintain the Raw Materials Testing Programs, support testing activities, ensuring compliance with regulatory and corporate directives for the QC Raw Materials laboratory that support the Multi Product Cell Culture (MPCC) DS facility and play a key role in the technical transfer and validations of new materials and methods.
- Provide technical leadership and guidance to the QC Site Operations team on the establishment of the laboratory procedures and practices, quality system elements, equipment qualifications, and cross-functional Raw Material Testing support for the MPCC/Warehouse facility.
- Participate in regulatory audits as the Raw Material Testing SME
- Participate in laboratory investigations to ensure timely close-out
- Directly involved in managing the technical transfer and validation of new materials
- Establish communication channels between all stakeholders to ensure visibility on end-to-end process.
- Participate in cross-functional teams to support Raw Material and Batch release.
- Participate in definition and establishment of the laboratory Quality Systems and Operational processes
- Participate in troubleshooting complex laboratory testing issues
- The ideal candidate should hold a minimum of a BSc. in Chemistry or related discipline and must have at least 5 years hands on experience in a Biopharmaceutical setting.
- Technical expertise: HPLC, GC, FTIR, UV, TOC, RAMAN and general Raw Material laboratory techniques.
- Experience with laboratory data systems, Empower, Tiamo, LIMS and CIMS would be an advantage.
- Experience in technical transfer and validation of chemical methods as well as cleaning method validation.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.