Newark Metro Area, NJ
PM SHIFTS ONLY
Purpose and Scope of Position:
Oversee and lead a team of associates in the manufacture of human blood derived components per Batch Records and Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment. Shift Supervisors adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations, review of executed batch records and assistance with quality investigations are required, as applicable.
Required Competencies: Knowledge/ Skills, and Abilities:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Sufficient vision and hearing capability to work in job environment.
Required Education and Experience:
Bachelors in a biologic science or engineering discipline, or relevant work experience including 3-6+ years of experience in cGMP biologics cell culture manufacturing. Experience in cell therapy manufacturing, or knowledge of the liso cell process is highly preferred.
Experience in any of the following areas is required: i. Aseptic processing in ISO 5 biosafety cabinets. ii. Universal precautions for handling human derived materials in BSL-2 containment areas. iii. Cell expansion using incubators and single use bioreactors. iv. Cell washing processes and automated equipment. v. Cell separation techniques and automated equipment. vi. Cryopreservation processes and equipment.
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
- Physical dexterity sufficient to use computers and documentation.
- Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
- Bend and Kneel
- Required to bend or kneel several times a day.
Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day. - Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
- Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
- Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
- Must be comfortable being exposed to human blood components.
- Must be able to be near strong magnets
- Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.