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:

• A basic knowledge of cGMPs
• Dissolution experience across multiple systems (manual, semi-automated and automated dissolution systems)
• Experience with biorelevant dissolution testing
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• Knowledge of applicable regulatory authority and ICH guidelines
• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
• Ability to utilize ELN, Empower is a plus, and Microsoft Excel and Word to perform tasks
• Ability to independently optimize/analyze analytical methods
• Good written and oral communication skills
• Time management and project management skills in a fast paced environment
• Problem solving and troubleshooting abilities
• Ability to work in a collaborative work environment with a team

• Develops, troubleshoots and conducts dissolution experiments in support of drug product process development
• Performs dissolution stability testing on drug products
• Maintains accurate records of experiments and results in an electronic laboratory notebook and authors reports as assigned in compliance with applicable SOPs and guidelines
• Designs, executes, and interprets experiments with a high degree of reliability and independence
• Performs basic statistical analysis of experimental data, where appropriate
• Maintains general lab equipment, including HPLCs and dissolution systems.
• Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations
• Performs other duties as assigned