Process Development and Manufacturing Scientist
Kelly Science is seeking a Clinical Manufacturing Specialist II to assist with portions of process development and biomanufacturing of clinical materials consistent with cGMP practices for treating patients with incurable diseases in phase I/II clinical trials.
- Lead human clinical materials biomanufacturing campaigns primarily as an operator.
- Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
- Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration.
- Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.
- Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.
- Plan and perform upstream and downstream components of assigned cGMP projects.
- Identify strategies for innovation in production systems and manufacturing processes.
- Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.
- Determine need for, devise and revise Standard Operating Procedures and Batch Records.
- Oversee cGMP grade raw materials acquisition for biomanufacturing.
- Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.
- Bachelor's degree in related scientific field and 2+ years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.
- Working experience with aseptic cell culture.
- cGMP clean room experience.
- Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
- Ability to work under deadlines with minimal supervision.
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Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Posting ID: 608236126Posted: 2021-03-05