Sr Scientist, Sterility

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Job Title: Senior Scientist

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:

As a Sr Scientist you will be responsible for working with stakeholders from development, clinical, commercial, and manufacturing organizations to develop and test phase-appropriate rapid, alternative microbiology methods (e.g., sterility, mycoplasma, MMV testing) and new technologies related to rapid microbial detection. This is a laboratory-based position and includes, but is not limited to, performing testing to assist in the development and validation of microbiology methods in support of aseptic manufacturing of clinical and commercial drug products, executing assays for technology transfer to commercial sites, and new technology evaluation/implementation.

Key responsibilities:

• Responsibilities include execution of methods within the laboratory, evaluation and implementation of rapid technologies to facilitate testing
• Providing data to interdisciplinary development teams in support of product development plans.
• Additional responsibilities may include the phase appropriate validation of traditional microbiological methods (bioburden and endotoxin).

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 and previous experience that provides the knowledge, skills, and abilities to perform the job
• GxP experience in analysis of pharmaceuticals, including analytical or microbiological methods.
• Effective multi-tasking and oral/written communication skills and be capable of working both independently as well as with the team, driving projects to completion with management oversight.

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.

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.

Benefits

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