Research Scientist - Qc, Gmp, Cell Culture

Associate Research Scientist / Research Scientist - Quality Control, GMP, Cell Culture , (Boston, MA)

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.

In this position you are responsible for the execution of various scientific analyses under cGMP guidance to evaluate the quality of raw materials, in-process materials, and finished goods. This role will assist with conducting and validating various biological and chemical quality control (QC) assays as well as executing method transfers for commercial QC lab in compliance with established standards.

Essential Functions:

• Starting / Building a commercial QC lab utilizing cGMP for Method Transfer.
• Performs technical reviews of raw data.
• Improving the laboratory—including managing reagents, materials, improving lab flows, et cetera—with minimal managerial support.
• Ability to perform method development transfers and qualifications.
• Assists in tracking and trending of QC data.
• Performs Quality Control (QC) testing of Cell and Gene Therapy in-process, release and stability samples.
• Typical test methods performed include assays in cell and gene therapy, potency, flow cytometry, and in-vitro differentiation.
• Records test results and maintains raw data and accurate laboratory records using cGMP guidelines.

At PPD, part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

To learn how PPD, part of Thermo Fisher Scientific can advance your career, apply now!

Education and Experience:

• Associate Research Scientist: With a bachelor’s degree comparable to 6+ years, with a master’s degree comparable to 4+ years, with a PhD comparable to 2+ years.
• Research Scientist: With a bachelor’s degree comparable to 8+ years, with a master’s degree comparable to 6+ years, with a PhD comparable to 4+ years.
• Bachelor''s degree or equivalent and relevant formal academic / vocational qualification
• Previous industry experience that provides the knowledge, skills, and abilities to perform the job:

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:

• Is dependable and able to work well within a team.
• Is proficient in the use of spreadsheets and word processing software.
• Have ability to problem solve by selecting appropriate alternative from defined options.
• Shows initiative; acts independently with management approval.
• Performs tasks with strict adherence to cGMP principles.
• Is optimistic and displays a positive attitude even during periods of adversity.
• Has an understanding of basic laboratory equipment and practices.
• Experience in a commercial QC lab setting.

Working Environment:

PPD, part of Thermo Fisher Scientific values the health and well-being 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 use and learn standard office equipment and technology with proficiency.
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to lift and move objects up to 25 pounds.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to work in non-traditional work environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!