QC Scientist/Project Manager III
South San Francisco, CA | Contract
Bayside Solutions is seeking a QC Scientist/Project Manager III to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
QC Scientist/Project Manager III
- The QC Scientist / Project manager III will be a member of the Protein Analytical Chemistry Validation Department (PAC-V).
- PAC-V is one of the departments in Analytical Development and Quality Control (ADQC) organization within Process Research and Development.
- 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 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.
- 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.
- 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.