Cell Lab - GMP, clean room, Cell culture, tissue culture
Responsibilities will include, but are not limited to, the following:
- Execute/implement Clinical Production batch records for the following areas: cell culture, cell harvesting, tissue processing (placenta), cryopreservation, etc.
- Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with timelines, and participate in clinical supply campaigns
- Coordinate daily laboratory tasks
- Contributes input toward the revision of Standard Operating Procedures (SOPs)
- Prepare and maintain cell culture reagents and media
- Ensure sufficient laboratory supplies for daily laboratory operations
- Ensure proper operation and perform routine maintenance of all laboratory equipment
- Assist other staff to complete all laboratory tasks as necessary
- Follow SOP's associated with processing of Clinical Grade cellular product.
- Responsible for entering processing data into Batch Records
- Proper handling and storage of products into a designated freezer or liquid nitrogen tank
- Operation of laboratory processing equipment, including
• Biosafety Cabinets and Clean Rooms within cGMP space
- Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices
- B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 2-3 years of relevant experience in cGMP setting
- Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs). Must be able to communicate effectively with other functional areas, and accrediting and regulatory agencies.
- Must have excellent organization skills and ability to handle multiple tasks
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
- Must have strong engineering or scientific knowledge appropriate for processing clinical grade cellular therapeutics
- Ability to consistently perform various manual laboratory duties and techniques on time sensitive material with accurate and precise manipulations.
- Knowledge of cGMPs and SOP development
- Excellent verbal and written communication skills
- A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.
- Employees must work in areas where posted Universal Precautions must be observed and practiced. There is repeated contact with potential infectious blood products with subsequent risks of acquired infections. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.
For Immediate Consideration, please send resumes to: [Click Here to Email Your Resumé]
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.