MSAT Analytics Scientist II PC 528
Miltenyi Biomedicine•San Jose, CA
•$120,278 - $141,593•Onsite
About The Position
This position is primarily responsible for leading the analytical transfer used in the testing of cellular therapy products into Process Sciences. This position may serve as a process owner and may drive medium scope continuous improvement projects and Business Process Improvement activities related to overall department goals.
Requirements
- Bachelor's or advanced degree from a four-year college or university in a biological or biomedical discipline.
- A minimum of 5-8 years progressive experience with clinical processing analytical testing in the cell therapy industry and/or cell culture operations in the biotechnology industry.
- Expert understanding of Immunoassays and quant and routine analytical methods, such as flow cytometry, Elisa and QPCR.
- Expert in one or more advanced methods, such as cytotoxicity and/or cytokine characterization.
- Advanced understanding of cGMP and regulations/guidance.
- Ability to interpret guidance documents and make technical recommendations.
- Strong technical writing and communication skills.
- Expert understanding of analytical transfer, qualification, and validation.
- Advanced understanding of statistical methods applicable to analytical transfer and qualification.
- 10-20% Domestic and International travel.
Nice To Haves
- Advanced Understanding of Quant and routine analytical methods.
- Familiar with 1 or more advanced methods.
- Advanced understanding of cGMP and regulations.
- Can read guidance documents and make technical recommendations.
- Sound technical writing.
- Advanced understanding of analytical transfer, qualification, and validation.
- Sound understanding in statistical methods
Responsibilities
- Liaison between PS and QC for analytics
- Support analytical transfer into PS, and into/out of QC
- Support stability program
- Participate in research and development activities
- Mentor junior employees
- Author and/or review and approve GMP documentation
- Author and/or review and approve protocols and reports
- Serve as process owner and drive medium scope CI projects
- Troubleshoot analytical issues, including investigation for root cause (OOS) and implementation of corrective and preventive action (CAPA) plans.
- Lead risk assessments, root cause analysis and similar activities
Benefits
- health, vision, and dental insurance
- 401(k) plan
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
