About the position
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 clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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. This is an onsite position located in Collegeville, PA. The Scientist possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows 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.
Responsibilities
- Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
- Work with multiple functional groups to meet business needs.
- Plan and organize work with periodic supervision.
- Set up and maintain analytical instrumentation.
- Train on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
- Ensure QA findings are addressed appropriately.
- Provide assistance and training to other team members.
- Problem solve, either independently or with assistance pertaining to extraction and/or instrumentation problems.
- Communicate project status to project leader.
- Perform work assignments accurately, and in a timely and safe manner.
- Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Requirements
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification AND 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job.
- 2+ years of previous experience in a QC microbiology laboratory.
- Demonstrated knowledge of multiple microbiological techniques such as: bioburden, bacterial endotoxins and sterility including USP general chapters USP , USP , USP.
- Proficient in Microsoft Excel and Word.
- Proven ability to interpret data by performing trend analysis.
- Proven ability in technical writing skills.
- Ability to independently optimize analytical methods.
- Proven problem solving and troubleshooting abilities.
- Good written and oral communication skills.
- Time management and project management skills.
- Ability to work in a collaborative work environment with a team.
Benefits
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
- Outstanding career and development prospects
- Innovative, forward-thinking organization
- Exciting company culture that stands for integrity, intensity, involvement, and innovation.
