Scientist - HPLC, GMP

at  Thermo Fisher Scientific

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.
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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR Masters degree
  In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

KNOWLEDGE, SKILLS AND ABILITIES:

• Experience in a regulated cGMP Lab
• Experience in analytical methodology, such as chromatography (HPLC/GC/IC), KF, UV and common compendial methods required. Experience in some specialty techniques required (LCMS, GCMS, PXRD, ICP, Dissolution, Disintegration).
• Experienced in laboratory systems (LIMS, CDS, ELN) required.
• Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
• Proven problem solving and troubleshooting abilities

• Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing for both drug substances and drug products)
• Understand corporate standards regarding code of conduct, safety, and GxP compliance.
• Responsible for compliance with all applicable Client policies and procedures.
• Document experimental data appropriately in laboratory documentation systems.
• Maintains laboratory equipment and optimize laboratory operations for safe and efficient use of time and resources.
• Troubleshoots equipment and experimental problems.