Sr Scientist, GMP Analytical Testing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Join us as Senior Scientist!

Job Title: Senior Scientist, GMP Analytical Testing

This is a fully onsite role based at our customer’s site in New Brunswick, NJ. 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.

Job Summary:
The Senior Scientist will validate and implement analytical methods to assess physical and chemical properties of pharmaceutical materials. This work is conducted in a highly-collaborative, multi-disciplinary team charged with the overall research & development of our active ingredients, formulated products, and the associated manufacturing processes. The Senior Scientist plays an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics.

Key responsibilities:

• Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, Karl Fischer titrations, etc.
• Transfers validated methods to customer labs, including BMS and partner-owned quality control (QC) labs.
• Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
• Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
• Documents / reviews laboratory work using laboratory notebooks /electronic notebooks that is detailed, timely and in compliance with GLP / GMP requirements.
• Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
• Reviews data for compliance and adherence to specifications and acceptance criteria.
• Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results.
• May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Prepares and/or reviews testing protocols and reports.
• Operates within and maintains the laboratory in an ‘audit ready’ status.
• Complies with Environmental Health and Safety Requirements
• Other duties as assigned by supervisor.

EDUCATION AND EXPERIENCE

Sr. Scientist:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar and 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.

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