Newark Metro Area, NJ
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.
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.
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.
o 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.
o 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.
o Execute experiments, batch records and documents using good Documentation Practices.
o Responsible for executing hands on equipment and facility cleaning/sanitizations, process setups reagent and compound sampling and subdivisions.
o Order, maintain inventory, and stock shelves for materials, consumables, standard solvents, supplies, and Personal Protective Equipment (PPE).
o Document all activities in batch records, notebook entries, equipment cleaning and use logs, reagent/compound receipt, sampling and use logs, or other worksheets.
o Capable of working with potentially hazardous materials in an isolator, containment, or gowned in PPE including a respirator.
o Under general guidance assists with the procurement, installation, repair, preventative maintenance, calibration, and troubleshooting of equipment including qualification activities (IQ/OQ/PQ).
o Assist with aspects of facility planning and scheduling.
o Assist with maintaining and controlling inventory of raw materials, intermediates, retains, and finished APIs associated with the kilo lab facility.
o Adhere to and sponsor all quality systems for the kilo lab area (SOPs, training, documentation, etc.) to ensure cGMP compliance with standards and regulations.
o Ensure that kilo lab activities meet all requirements for process safety and maintain compliance with all applicable safety and environmental standards and regulations.
o Assist with tracking performance metrics for kilo lab operations.
Assist all chemist and engineering staff who utilize the kilo lab area, by helping to establish and drive best practices for all unit operations and activities.
Develop and maintain effective relationships with partner areas, including Analytical Development, Quality, Drug Product Development scale-up facility, Laboratory Systems Management, Facilities group, EHS, etc. to support kilo lab activities.
General understanding of Root Cause Analysis and CA/PA methodologies.
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 lift up to 80 lbs. in support of equipment set-up and cleaning activities.
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.
Demonstrated hands-on experience, process/equipment problem solving, and mechanical aptitude skills.
Experience in operations involving highly potent compounds a plus.