Massachusetts Jobs

Work Schedule

Other

Environmental Conditions

Office

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 demonstrate 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.

Key responsibilities:

Provides a variety of review and analytical functions that occur in the Commercial Quality Control (CQC) Lab in MSAT supporting the commercial reference standard program. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

• Perform technical review of analytical data for both CQC Lab and reference standard

• Handle and fulfil reference standard shipment requests including aliquoting material for shipment

• Handle in-use and back-up reference standard inventory

• Generate, approve, and distribute COAs

• Use data analytics and tools to generate metrics and drive continuous improvement

• May lead OOT/OOS investigations, deviations, and identify corrective actions to prevent reoccurrence.

• Authors, reviews and approves data, SOPs, analytical methods, protocols and reports

• May perform laboratory activities and testing as needed

• Maintain accurate testing records and adhere to cGMP/GDP expectations

• May participate in planning, implementing, or reviewing method validations and/or method transfers

• Perform other laboratory duties as assigned

• Participates in compliance related teams working towards the goal of continuous improvement

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)

• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

• OR PhD

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:

Solid understanding of cGMP in a pharmaceutical setting

Solid understanding in analytical techniques in a QC/commercial setting (e.g. HPLC, GC, KF, ROI, XRD, TGA, etc.),

Including method validation/transfer

Experience with both drug substance and drug product (oral solid dosage forms) testing

Attention to detail

Effective interpersonal skills, both verbal and written

Working Environment:

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.