Critical Reagent Associate

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

Job Purpose:

• Maintain oversight of Biopharm critical reagents, reference standards to and from various R&D departments, commercial manufacturing organizations or contract manufacturing testing labs.
• Support and manage as required the method life cycles associated with Control Standards, apply appropriate statistical tools to asses Control Standards capability, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations.
• Support the QC Lab Operations with associated analytical method troubleshooting, process improvement, SOP and other quality document review/approval, business initiative/project management.

Essential Functions:

• Support management of Critical Reagent Program. Assist with qualification, distribution, and shipment of critical reagents, reference standards, and analytical cell banks to GLP and R&D labs globally.
• Maintain inventory of onsite critical reagents and reference standards.
• Support QC lab operations with analytical method troubleshooting, process involvement, SOP and other quality document review/approval.
• Support and manage as required the method life cycles associated with Control Standards, apply appropriate statistical tools to assess Control Standards capability, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations.
• Write critical reagent Records of Analysis.

Education and Experience:

Bachelor's degree in biochemistry or analytical chemistry plus a minimum of 1 year experience in the biopharmaceutical industry.

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:

• Candidate must understand biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (SDSPAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay, USP/EP compendial testing).
• Work experience in method qualification, validation, technology transfer, and stability testing.
• Cold Chain distribution, inventory management, and other logistical experience are highly desirable.
• Familiar with statistical trending.
• Strong Project Management skills.
• Strong technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes.
• Familiarity with FDA/EU/ICH and ROW regulations and guidance.

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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!