Jobs in Summit, NJ

About the role

This position is responsible for executing batch manufacture, setups, cleanouts, trouble shooting, subdivisions, sampling, and inventory maintenance in the DSD kilo-lab scale facility for drug substance process development and scale-up activities, associated with production of GMP and non-GMP drug substances and intermediates.

What you'll bring

• HS Diploma or Trade Certificate with minimum 8 years relevant experience in drug substance process development, GMP/non-GMP manufacturing, scale-up, and technology transfer in the pharmaceutical industry.
• Associates Degree with minimum of 6 years relevant experience.
• Bachelor of Science Degree with minimum of 4 year relevant experience, required in Chemistry/Chemical Engineering or related engineering/scientific discipline or relevant experience in lieu of degree.
• Relevant experience in Kilo Lab/Pilot Plant Operations, Small Molecule Process Development, GMP Process, Facilities, Operations, process development, technology transfer, and process safety.
• Ability to work in isolator / containment apparatus, or while gowned with PPE.
• Excellent verbal/written communication, collaboration, influence, multitasking, and software skills.
• Understanding and application of cGMPs and current regulatory standards in drug substance manufacturing for global clinical programs.
• Proven track record in scale-up and implementation of innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Ability to work with a sense of urgency, independently or collaboratively in a team.
• Ability to serve as a training resource and partner to others on kilo lab processing and GMP activities.
• Experience in operations involving highly potent compounds a plus.