Associate Scientist: GMP

at  Thermo Fisher Scientific

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 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 possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of 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. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous industry experience (0-2+ years) 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:

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

ESSENTIAL FUNCTIONS:

• Provide testing support for the Pneumo programs.
• Perform testing in a GMP lab and follow all applicable SOPs and STMs when performing the tests.
• Perform colorimetric 96-well plate-based tests such as anthrone, uronic acid, BCA, biotin, free polysaccharide.
• Perform HPLC and SEC-MALS analysis.
• Participate in the method qualification, validation, transfer as necessary.
• Perform trending of QC assays, reagents, assay controls, system suitability, standards.
• Perform release and stability testing.
• Support the SAP implementation in the Binney street QC.
• Participate in the qualification and management of critical reagents, reference standards.
• Assist in preparing SOP’s, technical protocols, reports, OOS/OOT/deviation investigations.
• Work with QC management in data analysis, peer review of analytical data.
• Work with the QC team to maintain and update inventories.
• Monitor controlled temperature units. Supporting initiation of stability studies and pull stability samples.
• Work collaboratively with different teams and groups.
• Perform additional duties and projects as assigned by the QC management.
  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!

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 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