Senior Manager, Analytical Operations & Quality Control
Job Posting for Senior Manager, Analytical Operations & Quality Control at NEW JERSEY INNOVATION INSTITUTE INC
BioCentriq is a Biologics CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations and quality professionals, work with our clients to translate groundbreaking treatments into the clinic. The novel therapeutics we focus on require constant innovation and creative thinking for the clinical translation and subsequent GMP manufacturing to be successful. The BioCentriq state-of-the-art facility includes PD labs as well as clean room space to support clinical manufacturing projects of our clients. This role will be primarily located at our GMP facility in Newark. However, the project responsibilities will require periodic travel to our Pilot Plant in South Brunswick, NJ. We are currently expanding our multidisciplinary team, seeking a Manager - Analytical Operation & Quality Control to support our Analytical Methods Development & Quality Control functions.
- Perform testing of in-process, final product, and stability samples.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Prepare and present continuous improvement projects to management.
- Comprehensive understanding of regulatory guidelines and can independently develop, write, and execute methods, protocols, reports, and other related documents.
- Perform peer review/Manager review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Perform assigned tasks within a CAPA, deviation, or project.
- Participate in complex projects and continuous improvement efforts.
- Take a leadership role for projects, as required.
- Draft and review technical documents (SOPs, protocols, reports, etc.).
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate continuous improvement to keep pace with a rapidly growing industry
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Job openings at NEW JERSEY INNOVATION INSTITUTE INC
Newark, NJ
Intern
Newark, NJ
Full Time
Newark, NJ
Full Time
Newark, NJ
Full Time
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