- Joining a team of highly qualified operators, participate in the daily, technical manufacture of the company's tissue products. Operate 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 tissue products.
- Technical processing of multiple tissue products with direct involvement in harvesting, processing, storage and release. Maintain and deliver sufficient supply of tissue products per internal sales forecast.
- 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.
- Direct involvement in process development, training activities and technical process transfers for existing and future products. Execute protocols to support manufacturing operations. As needed, provide daily technical updates to Technical Operations management.
- Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.
- As required, 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
- Experience with cells and/or tissue manufacturing. Understanding of human cell and tissue-based therapies
- Strong organizational and time management skills
- Ability to work well in a team environment
- 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
- B.S degree in Biology, Bioengineering or related scientific discipline
- 1-2 years' relevant experience with tissue manufacturing and operation within cGMP environments.
- Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
- Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
- Understanding of clinical cGMP manufacturing operations and related gowning
- Knowledge of GxP regulations (cGTP, cGDP, cGMP)
- Knowledge of procedure and batch record writing and creation.
- Experience in a fast-paced, scientific start-up environment
- Dynamic individual with the ability to communicate and engage others
- Independent and self-starting.
- Eager and adaptable
- 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.).
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Operator, Tissue Manufacturing - Florham Park, United States - Celularity
1 week ago
Description
Job Description
Job DescriptionDescription:About Celularity Inc.
Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta's unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.
Summary:
Celularity is seeking a dynamic individual to join a motivated team of clinical operators for the daily manufacture of multiple tissue product. Leveraging Celularity's 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.
Role and Responsibilities not limited to:
Minimum Qualifications (Must have)
Preferred Qualifications
Working Conditions
Celularity Inc. is an equal opportunity employer
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