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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.
-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.
- Order, maintain inventory, and stock shelves for materials, consumables, standard solvents, supplies, and Personal Protective Equipment (PPE).
- Document all activities in batch records, notebook entries, equipment cleaning and use logs, reagent/compound receipt, sampling and use logs, or other worksheets.
- Capable of working with potentially hazardous materials in an isolator, containment, or gowned in PPE including a respirator.
- Under general guidance assists with the procurement, installation, repair, preventative maintenance, calibration, and troubleshooting of equipment including qualification activities (IQ/OQ/PQ).
- Assist with aspects of facility planning and scheduling.
- Assist with maintaining and controlling inventory of raw materials, intermediates, retains, and finished APIs associated with the kilo lab facility.
- Adhere to and sponsor all quality systems for the kilo lab area (SOPs, training, documentation, etc.) to ensure cGMP compliance with standards and regulations.
- Ensure that kilo lab activities meet all requirements for process safety and maintain compliance with all applicable safety and environmental standards and regulations.
- 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. Serve as a resource of scientific and technical expertise regarding scale-up and kilo-lab operations.
- 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.
- Prepare technical reports, best practice documents, Standard Operating Procedures, work practices, publications and oral presentations related to kilo lab and project activities to enhance departmental knowledge and efficiency.
- 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.
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