Sr. Operator, Clinical Manufacturing
170 Park Ave, Florham Park, NJ 07932 Florham Park, NJ 07932 US
Pay Rates: 30-32/hr
Purpose of Job
Seeking an experienced dynamic individual to join a motivated team of clinical operators for the daily manufacture of multiple cell therapy products in support of the company’s clinical stage platforms. Leveraging new, state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.
Serve as an integral part of the daily, technical manufacture of the company’s cell therapy products. Leverage existing technical skills in classified manufacturing environments and clean room suites. Ability to gown appropriately for clean room/aseptic manufacturing is required.
Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured cell therapies. Maintain and deliver sufficient supply of cellular products for clinical studies in accordance with company timelines and participate in clinical supply campaigns.
Execution and daily completion of multiple batch records and entry of data into electronic databases. Ability to adhere to Good Documentation Practices. Consistently perform various clean room duties and techniques on time sensitive material with accurate and precise manipulations.
Work closely with Production Lead(s) in the implementation of departmental improvements and ensure open communication with area management. Routinely provide direct feedback.
Participate in process development, training activities and technical process transfers for existing and future products. Execute protocols to support manufacturing operations. Review and provide feedback on technical transfer documentation.
Routinely prepare and maintain cell culture reagents and media. Establish ongoing supply of donor cell stock and master cell banks.
Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.
Participate in the manufacturing environment cleaning program and work to assure all manufacturing suites, equipment and critical environments are maintained on schedule and per qualified methods.
Participate in the drafting of manufacturing operating procedures, batch records, material specifications and other related documents.
- BS degree in Biology, Bioengineering or related scientific discipline.
- 2-4 years’ relevant experience with clinical manufacturing, gowning, and operation within cGMP environments. Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
- Knowledge of GxP regulations (cGTP, cGDP, cGMP)
- Strong organizational and time management skills.
- Ability to work well in a team environment, eager, adaptable.
- Excellent verbal and written communication skills as well as strong focus and attention to detail.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
- Flexible scheduling required.
- Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
- Experience in a fast-paced, scientific start-up environment
- Dynamic individual with the ability to communicate and engage others
- Independent and self-starting.
- Position primarily operates for extended periods of time in classified clean room environments. Daily gowning in company provided scrubs, PPE and clean room attire.
- Fast paced, start-up environment which may periodically require work beyond standard business hours.
- Must be able to lift and transport at least 50 pounds
- Handling of potentially biohazardous material (human cells, tissues, etc.).
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.