Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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, or improving patient diagnostics and therapies, we are here to support them. When you join the team at Thermo Fisher Scientific, you'll do important work. Things like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Our work will have real-world impact, and we will support career goals. We will have the opportunity for continual growth and learning in an environment that will support development. We are seeking an energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing Process Development team.
Job Title: Manager, Analytical Development Location/Division Specific Information: US - Massachusetts - Plainville In the BioProcess Sciences (BPS) group our goal is to develop, characterize, and scale-up bioprocesses for robust manufacture of viral vectors to help our clients deliver lifesaving therapies to patients. As the Manager of Analytical Development (AD), You will develop and transfer method activities. You will act as domain expert in analytical development for viral vector while supporting detailed transfer and development of analytical methods from clients into Bioprocess Sciences lab. You will facilitate and collaborate within BPS to support a streamlined approach to Process Development. You will be supporting assay transfer to Quality Control (QC) for cGMP testing. This is a hands-on position. The ideal candidate shall have excellent lab skills, strong documentation skills, ability to analyze and summarize data to draw conclusions, program management, make data-driven recommendations, and collaboration skills to promote tight-knit relationships.
Expectations - Responsible for guiding scientists in the design and execution of phase-appropriate development/testing strategies including PCR based assays, immunoassay used for quantitation, and physiochemical characterization of viral vectors (Adeno-associated virus, lentivirus and other modalities)
- Lead transfer, gap assess, and establishment of already-developed analytical assays from clients. These assays will usually be in various state of development and the role of this position would be to identify and address these challenges with data-driven strategies
- Lead a team of scientists and associates responsible for Quality-by-Design method development for a portfolio of programs
- Review and evaluate data to ensure validity, accuracy, and precision
- Define priorities and objectives for staff to ensure timely completion of tasks and help them with prioritization in dynamic environments as per project timelines. Interact with clients, ensures accurate data and presentations to the clients
- Assist in preparing detailed analytical development report to support manufacturing and regulatory requirements
- Support calibration and maintenance of analytical testing equipment
- Stay updated with literature, internal SOPs, and the shifting agency guidances
- Collaborate with process development groups to effectively support process development/characterization testing and QC team for assay transfer for GMP testing
- Lead and facilitate Practical Process Improvement (PPI) initiatives
Education - B.S. in Chemistry, Biochemistry, Engineering or related field with 8 yrs., M.S. with 5 yrs., or Ph.D. with 3 yrs. of industrial experience including leadership experience
Experience - Experience with AAV, LV and Gene and/or Cell Therapy preferred
- Experience with analytical development PCR, ELISA, CE, SDS-PAGE, SEC-MALS, HPLC, cell-based assays, and other relevant assays
- Project management and the identification of shifting priorities
- Experience with analytical method development, across various platforms, (e.g. ELISA, HPLC, DLS, Raman, Chromatography, etc.) including quantitation of therapeutic proteins in biological matrices, metabolite identification and impurity profiling and piecing together the picture of what these assays are describing of the test material
- Experience technology transfer into a controlled environment
- Preferred experience:
- an understanding of global regulatory requirements including GLP, GCP, and the clinical trial process
- leading a small group, direct or indirect reporting structure, with a high retention rate and strong communication skills
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner, and safer. Apply today! 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.