Senior Scientist - QC Stability Data Review

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Senior Scientist - QC Stability Data Review

Shift: Full-Time; Monday – Friday; 8am-5pm EST

ONSITE/HYBRID:

This is a fully onsite role based at our customer’s site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  

Must be legally authorized to work in the United States without sponsorship. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

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.

Key responsibilities:

• Perform technical and quality reviews of internal and external documents, including raw data, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports and etc.
• Enter and trend stability data in SLIM system and generate stability timepoint summary reports.
• Establish/extend DS and DP shelf lives and generate shelf-life reports based on stability data.
• Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows.

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:

• Proven Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports, including raw data and external documents.
• Stability data in SLIM system and generate stability timepoint summary reports.
• DS and DP shelf lives and generate shelf-life reports based on stability data.
• Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows.
• Attention to detail and ability to multitask, review tons of data.

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 perfo