Senior Scientist - Analytical Development

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
We are looking for a highly motivated person to support analytical development and routine testing of new biological entities (NBEs) in cGMP environment. In this position as a Sr. Scientist, you should possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis independently. You should be familiar with method development / optimization and validation processes and be able to design and complete the experiments with minimal supervision. You should possess great verbal and written communication skills and be able to collaborate with cross-functional scientific teams. Instrumentation is mainly large molecule HPLC (such as SEC, IEX or RP) and/or icIEF and CE-SDS. Follow validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD
  In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrated knowledge of multiple applicable techniques such as: Compendial analysis, Coulometric Karl Fisher, UV-VIS, HPLC, icIEF and CE-SDS and other biopharmaceutical testing.
• At least one year of cGMP experience in a regulated lab is required.
• Proficient in Microsoft Excel and Word.
• Proficient in Empower.
• Proven ability to interpret data by performing trend analysis.
• Understanding and knowledge of general chemistry and separation science.
• Proven ability in technical writing skills.
• Ability to independently optimize analytical methods.
• Proven problem solving and troubleshooting abilities.
• Effective written and oral communication skills.
• Time management and project management skills.
• Statistical knowledge and experience are preferred.
• Ability to work in a collaborative work environment with a team.
• Ability to be flexible and be able to re-prioritize in a short notice to meet business needs.

• Performs a variety of complex sample preparation and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations for release and stability accurately and in timely and safe manner.
• Independently performs method validations and method transfers. Designs and completes experiments with minimal supervision.
• Documents experimental data appropriately and accurately in electronic laboratory notebook; assists in writing technical reports.
• Works with multiple functional groups to meet business needs.
• Plans and organizes work with periodic supervision.
• Sets up and maintains laboratory equipment, optimizes laboratory operations for efficient use of time and resources.
• Ensures QA findings are addressed appropriately.
• Mentors and trains other team members and assists in instrument troubleshooting and analytical problems.
• Communicates project status, data and technical issues to project lead and responds to leaders’ needs and questions.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
• Understands and adheres to corporate standards regarding code of conduct, safety, and cGMP compliance.
• Responsible for compliance with all applicable client policies and procedures.