Scientist - GMP

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 clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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.

The scientist will perform 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. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

Essential Functions:

• 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 for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

• Plan, perform, analyze, and document laboratory experiments in support of antibody discovery

• Culture and maintain mammalian cell lines and transient transfection for antibody production

• Experience with mammalian cell culture and aseptic technique desired

• Experience with liquid handling automation a plus

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification and 2 years of experience OR MS degree in relevant scientific 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:

• Knowledge of applicable regulatory authority, compendia 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 Microsoft Excel and Word to perform tasks

• Ability to independently optimize analytical methods

• 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

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.