QC Scientist, Analytical Chemistry / Project Manager
San Francisco Metro Area, CA
- Project management activities to support partners with project leaders and team members to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across the clinical product portfolio and testing sites (including CMOs and partners).
- Evaluation of corporate and regulatory policies and coordination of activities for implementation of these policies.
- Write the contents of Analytical Method Validation life cycle documentation (including master plans, protocols, test methods, and reports).
- Creates validation project plan (i.e., timelines and resources) and provides status updates to management.
- Utilize statistical tools for evaluation of method validation and trending data.
- Additionally, the candidate is expected to identify, evaluate, and implement continuous business process improvements.
- Excellent communication and presentation skills are essential.
- Proficient in project management skills and tools.
- A strong background and in depth knowledge in analytical chemistry across a wide range of technologies eg. HPLC, CE, etc.
- Must have extensive knowledge and experience of QC assay development and validation, and cGMP.
- Strong Quality orientation with attention to detail required.
- Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
- Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.
- Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external.
- Candidates should have a Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products.
- B.A. or B.S. degree in analytical chemistry or other scientific field with 8 years' experience in the areas of method development, validation and transfer.