Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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.

• This role is 100% onsite in Framingham, MA
• Performs a variety of routine to 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.
• Problem solves with assistance pertaining to extraction and/or instrumentation problems.
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Manages QC/QA responsibilities without supervisor or QA input.
• 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 in iLab (electronic lab notebook) for accuracy and compliance with reporting requirements

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Immunology, Chemistry, Biology, Molecular Biology or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4- 6 years') or equivalent combination of education, training, and experience.
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2-4 year) Or Ph.D. (+1 years' experience)
• Biopharmaceutical industry experience

• Demonstrated knowledge of one or more applicable techniques such as: HPLC, SEC, CE, icIEF, MS, SV-AUC, DLS, UV-Vis, FT-IR, FL, CD
• Experience with HPLC and Empower, and method optimization and troubleshooting.
• Knowledge of applicable regulatory authority, compendia, and ICH guidelines
• Ability to understand and independently apply GMPs and /or GLPs to everyday work about documentation and instrument use
• Ability to utilize Microsoft Excel and Word to perform tasks
• Good written and oral communication skills
• Time management and project management skills
• Problem solving and troubleshooting abilities
• Ability to work in a collaborative work environment with a team

• Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.