Labs FSP Scientist - QC, Chemistry

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

Summary:

As a QC Scientist, you will join the Cell and Gene Therapy Department to support QC operations in a fast-paced GMP environment.

Essential Functions:

- Collaborate with Analytical Development, as well as other teams, to help perform and assist in the development and

transfer of test methods, as well as the qualification of equipment

- Work cross functionally with internal (facility, validation, metrology) and external (CTL, instrument vendors) teams to

minimize day to day lab operations interruptions

- Identifying and creating processes that will ensure success within the QC lab

- Sample and data management

- Establish, write, and update Standard Operating Procedures (SOPs) in compliance with GMP guidelines as needed in

support of quality control operations

- Follows validated or experimental analytical procedures with periodic direct supervision.

- Sets up and maintains instrumentation

- Maintain QC equipment and perform regular performance verification/calibration as specified by equipment SOP

- Communicates project status to project leader.

- Performs work assignments accurately, and in a timely and safe manner

Qualifications:
Specific Knowledge, Skills, Abilities, etc: 
• Strong written, verbal, presentation, and interpersonal communication skills.
• Detail oriented with good organization skills.
• Ability to prioritize, independently manage and complete deliverables within given timelines. 
• Ability to problem solve and apply risk-based critical thinking in a technical environment.
• Demonstrated history of continuous improvement is desired.

Knowledge, Skills, and Abilities:

- GMP experience required

- 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

- Proficient in Microsoft Excel and Word (LIMS is a plus)

- Proven ability to interpret data by performing trend analysis

- Proven ability in technical writing skills

- Ability to independently optimize analytical methods

- Proven problem solving and troubleshooting abilities

- Good written and oral communication skills

- Time management and project management skills

- Ability to work in a collaborative work environment with a team

Education/Experience/ Licenses/Certifications:

- Bachelor's degree in Chemistry, Chemical Engineering, Scientific Field, or equivalent and relevant formal academic / vocational

qualification

- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years industry

experience).

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.

Preferred Experience:

- 2+ years of GMP QC testing experienc

In some cases, an equivalency,