Newark Metro Area, New Jersey
- Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical syntheses and processes for active pharmaceutical compounds.
- Remaining current with required GMP training and qualifications.
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.
- Proven track record in scale-up and implementation of innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances.
- Ability to serve as a training resource and partner to others on kilo lab processing and GMP activities.
- Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
- Execute activities in support of day-to-day operations of the Drug Substance Development kilo-lab facility, with responsibility for GMP and non-GMP processing activities.
-Ensure facility/equipment operations, setup, cleaning, maintenance, and calibration are completed and compliant with all relevant SOPs and regulations under the direction of kilo lab supervisor.
- Execute and assist with batch manufacture of GMP and non-GMP processing activities by preparing and operating equipment per procedures and batch record instructions, and completing subsequent equipment and area cleaning activities per established procedures.
- Execute experiments, batch records and documents using good Documentation Practices.
- Responsible for executing hands on equipment and facility cleaning/sanitizations, process setups reagent and compound sampling and subdivisions.