FSP - Scientist - Analytical Development , Small Molecule

Work Schedule

Environmental Conditions

Job Description

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.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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.

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.

As a Scientist you will conduct analytical testing using techniques such as HPLC/UPLC, Dissolution, Karl Fischer, and GC to support analytical method development and drug product development.

• Support analytical method development and drug product development.
• Hands-on experience and knowledge in small molecule pharmaceutical analysis.
• Critical analysis of analytical results with the goal of improving the robustness of analytical methods and enhancing understanding of key drug product quality attributes.
• Reviewing, interpreting, and communicating analytical results and conclusions effectively, both orally and in writing.

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

• Experience with various analytical techniques including HPLC/UPLC, Dissolution and KF. Experience with GC is a plus.
• Pharmaceutical industry experience in the core analytical techniques of HPLC and Dissolution.
• Knowledge in analytical method validation and knowledge of analytical method validation requirements as defined by ICH.
• Experience in analytical development in support of drug product formulation development.
• Experience with Empower is desirable.
• Experience in performing dissolution testing using biorelevant media, for active ingredients and drug formulations to facilitate biopharmaceutics risk assessment and support drug product development is a plus.
• Ability to execute and document scientific experiments and effectively communicate study results.
• Experienced in drafting and delivering analytical studies, with a strong ability to follow written procedures and protocols.
• Demonstrated ability to work independently as well as collaboratively within cross-functional teams to achieve shared objectives.
• Strong problem-solving and troubleshooting skills.
• Strong written and oral communication skills.

Familiar with USP, ICH and other compendial requirements.

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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!