Sr. Scientist – Quality Compliance / Change Control

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

FSP – Sr. Scientist – Quality Compliance / Change Control

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

ONSITE:

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.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Be the Analytical Development (AD) point of contact for change controls. Responsibilities include but not limited to: participate in change control review, evaluate impact to AD and collaborate with SMEs for joint assessment, initiate, track and close change control record
• Support internal audit programs to ensure compliance and pre-approval inspection readiness
• Assist in the revision of governance SOPs for AD, including but not limited to Method Validation and Method Transfer, Establishing Specification
• Review analytical data. Perform data verification to ensure accuracy and completeness of information presented in analytical documents and regulatory filings (IND/BLA)
• Propose and implement ways to ensure and improve timely closure of change control, investigation, CAPA, ELN and completion of trainings
• Support other analytical development activities as needed

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:

• Relevant Analytical Development, Quality Control or Quality Assurance experience is required
• Attention to detail and follow up with collaborators to ensure timely completion of assignment
• Ability to communicate to a wide variety of audiences, exchanges complex and sensitive information and gain alignment around a proposed action
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Excellent technical writing skills are essential
• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
• Hands-on experience and In-depth knowledge of change control, deviations, CAPA and investigation
• Experience in biologics, gene and cell thera