Lead Manufacturing Assoc (DR)
Job Location: Princeton, NJ
Date Posted: 2020-04-20
Candidate will join a well-funded clinical-stage LVV and AAV gene therapy company (biologics) with a broad pipeline in multiple pediatric rare disease clinical indications in US & EU. This company was one of the top performing biotech stocks in 2018. This technical and leadership position is a key role in manufacturing operations. The ideal candidate will have 5+ years’ experience performing large scale cGMP clinical or commercial manufacturing of viral vectors, biologics or monoclonal antibodies at a leading pharma or biotech organization. As a Manufacturing Associate, you will be responsible for manufacture of viral vector therapies. Additional responsibilities include set-up, operation and cleaning of equipment, equipment and process monitoring, upkeep of cGMP equipment and manufacturing area, completing and reviewing batch documentation, coordinating material requirements and other functions supporting cGMP manufacture of viral vector therapies. The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and process development highly valued.
Perform all upstream and downstream unit operations required to manufacture viral vector therapies including; cell line initiation (vial thaw), cell line scale-up, bioreactor operations, transfection, harvest clarification, TFF, column packing, chromatography and bulk drug substance fill. Perform all activities using industry standard aseptic techniques, and following accepted cleanroom behaviors and controls (i.e., gowning, flows; sanitization, segregation). Lead junior Mfg Associates to complete assigned daily work activities safely and per cGXP. Train, coach and mentor others on all manufacturing unit operations, procedures, and equipment; train others on non-manufacturing procedures and systems. Schedules manufacturing support activities with Logistics, Maintenance, Metrology, EM, QC and QA teams. Develops weekly and daily manufacturing schedules and staff assignments that effectively and efficient utilize resources and meet overall manufacturing objectives. Maintain cGMP equipment and manufacturing areas in a safe and compliant readiness state; follows and enforces all safety, regulatory and compliance requirements. Performs complex equipment troubleshooting; coordinates and schedules equipment PM and calibration; Champions process, equipment, facility, safety and/or compliance improvements; provides technical input and review of cross functional cGMP documents. Provides facility, equipment and cGMP input to tech transfer process, oversees tech transfer and validation activities, including offsite FAT. Authors, follows, completes and reviews all cGMP batch documentation including Batch Records, Forms, equipment printouts, Sample Requests and Test Results. Lead cross functional collaboration with others from diverse backgrounds.
High School Diploma with 8+ years’ experience or B.A./B.S. with 5+ years’ experience in large scale pharma/biologics manufacturing. Direct experience operating, troubleshooting and maintaining upstream or downstream process equipment such as stirred bioreactor, depth filtration system, TFF system, chromatography system, tubing welder / sealer, filter integrity tester, reach-in incubator, BSC and automated cell counter. Demonstrated experience using and applying animal cell culture techniques and principles from shake flask to 2,000L bioreactor scale. Demonstrated ability to accurately complete, compile and review cGMP batch documentation per cGDP requirements. Must have experience working in a GMP
egulated manufacturing environment. Demonstrated experience planning and performing cGMP facility and utility validation; prior experience planning and executing equipment FAT, SAT, IQ/OQ/PQ. Subject Matter Expertise with material, document and Quality Management System applications such as ERP, LIMS, MES, and/or ZenQMS solutions. Ability to work independently to lead manufacturing staff to complete tasks with attention to detail and right-first-time mind set. Ability to monitor the daily activities and performance of junior Manufacturing Associates. Ability to coach and mentor subordinates; ability to assume responsibilities of Manufacturing Supervisor or Manager as required/directed. Sense of ownership and pride in your performance and its impact on company’s success. Critical thinker and problem-solving skills. Team player. Good time-management skills. Great interpersonal and communication skills. High School Diploma with demonstrated
elevant hands-on experience. A.S. or B.S. in Life Science, Biotechnology, ChemE, or similar relevant field preferred.
Please contact Derek Reilly at firstname.lastname@example.org
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