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.

Summarized Purpose:

Possesses a detailed understanding of laboratory procedures and can reliably conduct sophisticated analysis with increased independence. Performs a variety of sophisticated 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.

Key responsibilities:

• Performs a variety of sophisticated 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.

• Works with multiple functional groups to meet business needs.

• Plans and coordinates work with periodic supervision.

• Sets up and maintains analytical instrumentation.

• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.

• Ensures QA findings are addressed appropriately.

• Provides assistance and training to other team members.

• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.

• Communicates project status to project leader.

• Performs work assignments accurately, and in a timely and safe manner.

• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Keys to Success

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills and Abilities:

• Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC

• Proficient in Microsoft Excel and Word

• Proven track record to interpret data by performing trend analysis

• Proven track record 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

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.