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Principal Scientist

System One

This is a Full-time position in South Brunswick, NJ posted December 2, 2019.

Title: Principal Scientist
– R&D Orals Hours: M-F Full Time, 1st Shift Location: Dayton, NJ Responsibilities: Lead formulation development of complex products from development to ANDA filing and provide technical leadership to the RD team.

Lead formulation development of complex products from development to ANDA filing and provide technical leadership to the RD team.

Provide scientific input for multiple projects and act as Subject Matter Expert.

Review literature, reports, protocols and approve them.

Discuss, prioritize and plan work with external functions such as ARD, TS & Manufacturing.

Provide administrative approvals.

Provide support for DEA inventory activities.

Independently contribute to drafting high quality product development reports for ANDAs and NDAs.

Qualifications: M.S.

or Ph.D.

in a Pharmaceutical Sciences related area preferred Minimum 6-10-years’ experience in generic and 505b2 product development.

Experience in developing controlled substances and DEA related regulations.

Experience in developing complex modified release products.

Hands on experience with multiple unit operations desired.

Experience in technical problem solving using techniques such as FMEA/ root cause analysis and QbD.

Experience in working with DEA controlled drug substances and relevant regulations.

Joule, a System One division is a leader in specialized workforce solutions and integrated services.

With more than 6,000 employees and roughly 50 offices throughout the U.S.

we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.

For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.