Investigator, Analytical Technology Transfer
- Bachelors degree in Biochemistry, Chemistry or Biology and at least 5 years relevant experience OR PhD/MS degree in Biochemistry, Chemistry or Biology with minimum 3 years relevant experience
- Prior experience and familiarity with GLP regulations
- Prior experience with and thorough knowledge of cGMP requirements
- Previous Biopharmaceutical experience
- Experience in the use and application of USP, EP and ICH guidelines relative to analytical method qualification (fit for use), validation and methods transfer
- Industry experience with GMP testing in a team based laboratory environment using biopharmaceutical associated analytical methods (e.g. Capillary Gel Electrophoresis, Capillary Isoelectric Focusing, SEC/CEX-HPLC, UV/VIS, Bioassay)
- Familiarity with regulatory requirements and expectations as they relate to specification development and participation in the regulatory submission processes is also preferable.
- Good communication skills and experience in working within a team or matrix environment is essential.
- Occasional domestic or international travel required.
The Analytical Technology Transfer and Validations team has positions open at the Senior Scientist level. This team is responsible for the coordination, design, execution and oversight of analytical method transfers and validation requirements to support all phases of biopharmaceutical pre-clinical development through commercial release. These positions do not involve routine hands on laboratory bench work, and focus on the overall management of the analytical technology transfer, validation and related activities.
- Collaborate with internal development groups and serve as a liaison on technical issues with both internal and external contractors.
- Support the knowledge sharing and effective transfer of analytical methods to and from designated testing sites.
- Provide strong technical writing abilities and experience in authoring and modifying method SOPs, qualification/validation protocols and technical reports.
- Provide data review to ensure and monitor the ongoing performance of analytical methods.
- Own and manage method life cycles, apply appropriate statistical tools to assess assay capability, and develop method transfer/validation strategies consistent with ICH requirements and current regulatory opinion.
- Apply a strong working knowledge of biopharmaceutical quality control or development laboratory environments using FDA/ICH regulations and guidance.
- Work closely within and across interdepartmental matrix teams to ensure harmonization of release, stability and technology transfer testing practices.
- Contribute to product specification development and ensure alignment with process and method capabilities.
- Actively involved with project matrix teams as assigned to support the progression of the analytical work package from development through commercialization.
- Ability to work independently and collaboratively, ensuring appropriate change management is utilized.
- Contribute to the authoring and review of CMC sections for regulatory submissions including INDs, BLAs, and related documents.
You may apply for this position online by selecting the Apply now button.
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