Labs FSP Scientist

Title: Sr Scientist – Bioburden, Endotoxin

Location: New Brunswick, NJ

100% onsite position

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 partnership that allows our customers to benefit from 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.

Responsible for working with customers from research and development, clinical, commercial, and manufacturing organizations to ensure microbial control for manufacturing environments. This is a laboratory-based position and includes, but is not limited to, performing testing to assist in the development and validation of microbiological methods in support of aseptic manufacturing of clinical drug products, executing assays for technology transfer to commercial sites, and new technology evaluation/implementation. Responsibilities include performing environmental methods or microbiological methods (bioburden, endotoxin) within the laboratory or manufacturing facility, and providing data to interdisciplinary development teams in support of product development plans.

• Bachelor's degree in lab sciences such as Microbiology, Biology, Biochemistry, Material Science, Immunology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’ of work experience, or Master’s degree)
• 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.

• 2 years of experience in the analysis of pharmaceuticals, including microbiological, and analytical methods
• Strong aseptic and sterile technique experience
• Bioburden, endotoxin testing
• Working familiarity with cGMP practice and safety awareness for analytical laboratories (at least one year)

• Knowledge of Dissolution methods developing and testing
• Ability to independently optimize analytical methods and perform root cause analysis for method investigations
• Strong analytical skills
• Proven problem solving and troubleshooting abilities
• Effective written and oral communication skills as well as presentation skills
• Time management and project management skills
• Ability to independently review and understand project proposals/plans
• Experience with Electronic notebook required.
• LIMS experience required.

Below is listed the working environment 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.
• As a condition of employment with Thermo Fisher/PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.