Senior Research Scientist

4 weeks ago

New Brunswick, New Jersey, United States Thermo Fisher Scientific Full time
Work with Us

At Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. Our team is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We provide our colleagues with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

We're seeking a highly skilled Senior Research Scientist to join our Analytical Services team. As a key member of our team, you will be responsible for performing pharmaceutical manufacturing equipment cleaning verification cGMP activities, analytical method validation, and providing analytical support for clinical and development for Small Molecule New Chemical entities and Investigational Medicinal Products.

Key Responsibilities:
  • Development and validation of Total Organic Carbon (TOC) and Liquid Chromatography (HPLC) methods
  • Conducting and reviewing CV sample analysis
  • Authorizing CV method/validation reports and performing change control associated with the method revisions
  • Maintenance of TOC/HPLC instruments
  • Assess impacts to CV testing as a result of clinical manufacturing and compound permitted daily exposure limit changes
  • Collaborate with clinical manufacturing for periodic procedure revisions and assessment of risks
  • Performs analytical cGMP activities and provide technical expertise for evaluation and feedback of methods
  • Provides technical expertise and troubleshooting for technical problems and investigations
  • Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs
  • Technology transfer of analytical methods to external BMS partners
  • Provides input into audit readiness and expertise for internal and regulatory inspections
  • Effective teamwork and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing, and filing requirements meet associated clinical timelines

Requirements:
  • Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, or pharmacy, and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years')
  • OR Master's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years')
  • OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years')

Working Environment:

This role requires the ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. You will be able to work upright and stationary and/or standing for typical working hours. You will also be able to lift and move objects up to 25 pounds. You may have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. You will be able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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