Thermo Fisher Scientific Manager, PS Analytical in Cambridge, Massachusetts
Manager, Process Sciences Analytical
Requisition ID: 158192BR
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Cambridge, MA | Pharma Services Group Viral Vector Services
The Viral Vector Services (VVS) business unit is a key component to our growth trajectory within Thermo Fisher Scientific's Pharma Services Group focused on contract development and manufacturing services. At Viral Vector Services (VVS), we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
Manager in Process Sciences, Analytics will lead a team of scientists, and supervisors to support the development, qualification, and execution of cell-, nucleic acid, protein-based assays for various process characterization studies. Manager will collaborate closely with process characterization leadership and clients for technical discussions.
The candidate will review data, study reports, and perform statistical analysis for the analytical data.
Manager will also oversee the functioning of the PS Analytical laboratories, which includes personnel, materials, and equipment management.
What will you do?
Recruit and develop staff to execute department functions; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.
Work in a cross-functional manner and identify business process improvement opportunities and devise solutions that will enable technical teams to maximize capacity and revenues.
Manage scientists and supervisors to develop, validate, and assess analytical methods such as but not limited to qPCR, ddPCR, ELISA, liquid chromatography (LC), capillary electrophoresis (CE), analytical ultracentrifugation, and DLS, MALS for process characterization of viral vectors.
Work closely with process development, manufacturing, quality, and project management teams to execute assays to meet customers' need.
Lead technology transfers from process development to QC and/or from client to Viral Vector Services.
Develop, revise, and review SOPs, work instructions, test records, and test reports while maintaining schedule adherence for analytical deliverables.
Represent the team on CMC-related discussions with clients (e.g. investigation, regulatory, science and technology)
Participate in the design, review, critique and interpretation of analytical data. Perform statistical analysis and present the conclusions to the team.
Investigate deviations, trends, conduct root cause analysis, and implement corrective action for analytical methods.
Stay current with new technologies, regulatory issues, safety protocols, and scientific literature in the area of gene therapy to differentiate VVS offerings. How will you get here?
- Master's degree required in chemistry, biomedical/manufacturing engineering, molecular biology, virology or a related field. PhD preferred
6+ years of experience with Master's or 3+ experience with Ph.D. in managing analytical lab and scientists/supervisors
Development, qualification and/or validation of chromatographic/separation methods (HPLC, GC, CE-SDS, LC-MS etc.) and/or light scattering methods (DLS, MALS etc.)
Technical expertise in cell based, nucleic based or protein-based methods with significant laboratory documentation experience
Knowledge and experience with molecular and cell biology, virology and/or immunology is highly desirable
Project management skills with ability to work with cross-functional teams
Excellent troubleshooting skills and ability to solve complex technical issues
Familiarity with GLP requirements; some knowledge of cGMP requirements of biopharmaceutical manufacturing
Knowledge, Skills, Abilities
Knowledge of analytical assay principles and procedures, and related instrumentation
Technical expertise in cell based, nucleic based or protein-based methods
Knowledge of cell and gene therapy vector production is desirable
Experience with method validation
Self-motivated, detail oriented, and possess excellent planning skills
Ability to function in a rapidly changing environment & handle multiple priorities
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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