Thermo Fisher Scientific Manager, Bioanalytical in Saint Louis, Missouri
Title: Manager, Bioanalytical
Location: Greenville, NC
Division: Pharma Services Group (PSG)
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.
How will you make an impact?
Investigate, create, and validate new scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of projects. Mainly involved in pre-clinical and clinical stages of drug development. Work on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. Lead discussions with clients with a high level of technical proficiency. Lead a team of scientists that validate analytical methodologies for clinical, scale-up, and/or registration batches, including technology transfer and stability of projects from clients.
What will you do?
Lead a team for development and validation of analytical methods that meet or exceed the expectations from clients and provide innovation as necessary. Develop realistic proposals and timelines.
Serve as a leader and mentor for scientists in the laboratory regarding technical knowledge, work ethic, and attitude.
Coordinate research from industry practices and processes and apply to innovative drug development for client products.
Present recommendations internally and to clients. Lead a team of scientists; may lead multiple projects, including managing project timelines and deliverables.
Represent Analytical Development in customer meetings to receive/deliver information, requests and requirements.
Ensure that all deviation investigation, out-of-specification or aberrant results and process changes; troubleshooting of assay and instrumentation issues are completed in a timely manner.
Guide and advise during implementation of new methodologies and processes.
Be a liaison with internal scientific, manufacturing, quality, and laboratory functional areas to ensure business processes are efficient.
Investigate, evaluate, and recommend the purchase of laboratory equipment.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing
Practices, Good Laboratory Practices and Safety guidelines.
Maintain the necessary compliance status required by company and facility standards.
How Will You Get There?
Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science. Advanced
Typically requires 12 years of progressive scientific experience (9 years in a related life sciences
field, pharmaceutical experience preferred). Minimum of 5 years of management experience
If related Master's degree, 10 years of related experience preferred.
If related PhD, 6 years of experience preferred. Experience working directly with clients.
Knowledge, Skills, Abilities:
Proven excellence in the understanding and application of bioanalytical chemistry for meeting product development challenges.
Demonstrated expertise in optimizing and qualifying analytical methods for biologics. Hands-on
experience with common bioanalytical techniques: SDS-PAGE electrophoresis, capillary
electrophoresis (cIEF, icIEF), HPLC/UPLC, ELISA, residuals, stability, and potency assays
Experience managing groups in the development of analytical procedures.
Proven ability to train team members to handle bioanalytical development projects within agreed
Excellent knowledge of scientific methodology and development as related to the pharmaceutical
Thorough knowledge of Good Manufacturing Practices
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
Excellent critical and logical thinking skills
Effective written, interpersonal, and presentation skills, including managing technical discussions
with internal and external clients. Ability to work on multiple projects simultaneously
Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation,
Ability to keep current with scientific literature and industry trends relating to process technologies.
Ability to develop technical solutions
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.