Cell Specialist I/II (Monday-Friday)
Job Req code: 961
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.
This is a Monday-Friday, 7:30am-4:00pm position, with initial training taking place Monday - Friday for approximately 2-3 months. The ideal candidate for this job will participate and lead the manufacture of HEP & HDF cell banks under direct supervision from the department manager. He/she will perform and manage all tasks required to produce cells, i.e. tissue dissociation, spinner preparation, seeding, maintenance and harvest of cells, in a class 10,000 clean room environment in a safe and timely manner. Activities will include production/expansion of cell banks, creation of test cells, senescence of Master Cell banks, and production of range finders and G100 range finders, for a smooth translation into production. With minimal supervision, he/she will be required to multitask by working independently while supporting and working with the team with on-going cell banking priorities. This position requires a high level of technical expertise in Cell Banking and Cell Culture, thereby providing support to ongoing manufacturing operations. Strong values and behaviors and a sense of urgency for projects supporting Apligraf production are essential and required.
This position requires a high degree of manufacturing competence with a strong understanding of quality control and quality assurance concepts and the interrelation with cGMP manufacture of cellular products. This position involves close collaboration with process development, manufacturing, quality control, and quality assurance groups.
Knowledge and experience with equipment operation is required (e.g. incubators, controlled rate freezers, centrifuges, biosafety cabinets). Compliance to Standard Operating Procedure is essential to ensure that the cell banking and tissue processing suites are in compliance and operational at all times.
- Dissociation of tissue and manufacture cell banks according to established procedures
- Maintenance of cell bank inventory in compliance with AATB, FDA , state and local regulations
- Adherence to all protocols, policies, regulatory requirements, cGMPs, and safety guidelines
- Conduct batch record reviews with team and transfer to ensure that documentation is complete and in compliance
- Harmonization with QC and Cell Culture for Cell Bank testing
- Responsible for the review/transfer of completed batch records to Quality Assurance in a timely manner
- Proficiently operate equipment according to designed procedures
- Maintain required records & adherence to established guidelines for quality control procedures, cGMP and safety
- Assist in maintaining databases for trending, and analyzing cell culture technical data
- Provide technical and operational support and problem solving capabilities, as needed
- Coordinate the implementation of corrective measures to remedy deficiencies cited in audits of the manufacturing environment
- Proficiently function within a Class 100,000 and/or Class 10,000 clean room environment, ensuring personal and product safety
- Cell culture of mammalian cell banks using cell culture methods that may include T-flasks, cell factories, and spinner flasks, and cryopreservation of cell banks.
- Responsible for ensuring all appropriate manufacturing documents are current and updated as required and that documentation is consistently produced with a high level of accuracy and clarity
- Proven technical and scientific proficiency
- Ability to communicate effectively with other departments
- Performs additional duties as assigned
- Weekend work/coverage is required, when necessary
- Demonstrated expertise in manufacturing/aseptic techniques and GMP requirements
- Proven organizational and documentation skills
- Problem solving abilities
- Excellent communication skills
- Demonstrated leadership ability
- Cell counting on a hemocytometer
- Basic computer skills with a working knowledge of Microsoft Word and Excel
- Ability to work independently as well as in a team environment
- Manual dexterity
- Ability to work in a clean-room environment for extended periods
Preferred Education and Experience
- Associate’s Degree or Bachelor’s Degree in the biological sciences with 3+ years of experience, or 5-7 years of experience in biotechnology or related field
- Experience in aseptic technique and experience working in controlled clean room protocols
- Must be able to be gowned in a clean room for extended periods
- Repeating motions that may include the wrists, hands and/or fingers
- Approximately 6.5 hours per day standing
- Occasional lifting of objects up to 25 lbs.
- Medium work
A pre-employment physical and lift test will be required for this position once an offer has been accepted.
- Can be exposed to cold temperatures (cold rooms and walk-in freezers).
- Occasionally around loud noises.
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