Sr Scientist, Sterility

Thermo Fisher Scientific•New Brunswick, NJ

4d•$73,000 - $85,000•Onsite

About The Position

The Senior Scientist is a fully onsite, laboratory-based role at a customer site in New Brunswick, New Jersey. The position works with stakeholders across development, clinical, commercial, and manufacturing organizations to develop and test phase-appropriate rapid and alternative microbiology methods, including sterility, mycoplasma, and MMV testing, as well as technologies for rapid microbial detection. Work supports aseptic manufacturing of clinical and commercial drug products and includes method development and validation, testing, technology transfer to commercial sites, and evaluation and implementation of new technologies. The role provides data to interdisciplinary development teams in support of product development plans and may also involve phase-appropriate validation of traditional microbiological methods such as bioburden and endotoxin. Applicants must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

Bachelor’s degree in laboratory sciences or a similar field, such as Chemistry, Biochemistry, Material Science, Immunology, Biology, or Molecular Biology, plus comparable to 4 or more years of relevant experience; or a master’s degree plus comparable to 2 or more years of relevant experience; or a PhD and relevant experience.
GxP experience analyzing pharmaceuticals, including analytical or microbiological methods.
Effective multitasking and oral and written communication skills.
Ability to work independently and as part of a team, driving projects to completion with management oversight.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to work in non-traditional work environments.
Ability to use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

An equivalent combination of appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

Execute microbiology methods in the laboratory.
Evaluate and implement rapid technologies to facilitate testing.
Perform testing to assist in the development and validation of microbiology methods supporting aseptic manufacturing of clinical and commercial drug products.
Execute assays for technology transfer to commercial sites.
Evaluate and implement new technologies related to rapid microbial detection.
Provide data to interdisciplinary development teams in support of product development plans.
Work with stakeholders from development, clinical, commercial, and manufacturing organizations.
Potentially validate traditional microbiological methods, including bioburden and endotoxin, in a phase-appropriate manner.

Benefits

Competitive remuneration and eligibility for a variable annual incentive bonus.
Choice of national medical and dental plans and a national vision plan, including health incentive programs.
Employee assistance and family support programs.
Commuter benefits.
Tuition reimbursement.
At least 120 hours of paid time off (PTO).
10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability in accordance with company policy.
401(k) retirement savings plan.
Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
Career and development prospects.