MSAT Analytics Scientist II PC 528
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. When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
