Assoc Research Scientist - Commercial Testing

Thermo Fisher Scientific - Summit, NJ

Full-time - Mid Level

Summit, NJ

10,001+ employees

Computer and Electronic Product Manufacturing

About the position

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 leverage 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. Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once you become a part of Thermo Fisher's Clinical Research Group team. As an Associate Research Scientist, you will work in an analytical team supporting the entire commercial, small product portfolio. The position will be a blend of analytical chemistry lab work and administrative duties. The essential duties and responsibilities include, but are not limited to, working in a GMP laboratory performing method validations and transfers, performing HPLC, dissolution, method validation, method transfer, and change control tasks as needed, assisting in laboratory investigations at commercial sites, method troubleshooting, data review and analysis, authoring commercial methods into organization systems, initiating and managing analytical test method change controls, and supporting documentation change activities within the Pharma Analytical Sciences group.

Responsibilities

• Work in a GMP laboratory performing method validations and transfers.
• Perform HPLC, dissolution, method validation, method transfer, and change control tasks as needed.
• Assist in laboratory investigations at commercial sites; method troubleshooting.
• Data review and analysis.
• Author commercial methods into organization systems.
• Initiate and manage analytical test method change controls.
• Support documentation change activities within Pharma Analytical Sciences group.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification AND 6+ years of experience that provides the knowledge, skills, and abilities to perform the job.
• OR PhD in relevant field AND 2+ years of experience that provides the knowledge, skills, and abilities to perform the job.
• Solid understanding and knowledge of general chemistry and separation science.
• Experience in a regulated GMP lab.
• Experience using QMS system such as Infinity to manage change controls.
• Experience with separations techniques (HPLC, UPLC, GC, etc.).
• Experience with dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
• Experience in reviewing data for accuracy, compliance, and completeness.
• Experience with Empower or equivalent chromatographic integration software.
• Experience with ELN and/or LIMS systems is a plus.
• Familiar writing technical reports.
• Proficiency on technical operating systems.
• Proven problem solving and troubleshooting abilities.
• Effective oral and written communication skills.
• Ability to work in a collaborative work environment with a team.

Nice-to-haves

• Experience with ELN and/or LIMS systems is a plus.