Production Associate I

• Benefits: 401(k) matching, adoption assistance, dental insurance, health insurance, employee assistance program, flexible spending account, free parking, health savings account, paid parental leave, paid time off, tuition reimbursement, vision insurance, wellness program

• Requirements: High school diploma or equivalent required. Bachelor’s degree or Biotech certificate, quality systems regulations (cGMP) knowledge and clean room experience preferred but not required. A pre-employment lift test and physical may be required for some positions within Manufacturing. Aseptic Technique and cleanroom protocol experience desired Knowledge of standard lab techniques and equipment (eg. Balances, pipettes, stir bases, pH meters etc.) Ability to work in a cleanroom environment, for extended periods of time. Dexterity, coordination, and some lifting are required. Ability to work independently as well as in a team environment.

• Responsibilities: Responsible for manufacturing our cellular-based products according to established Master Batch Records and Operating Procedures under aseptic conditions. Perform all tasks associated with our HTP/collagen products such as layer separation, cleaning, spreading, cutting, milling, and packaging, for all HTP/collagen products with supervision in compliance with Quality Systems regulations and according to established procedure. Responsible for adherence to all Operating Procedures, Batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines. Review batch records for completeness and accuracy, as well as compliance with all protocols. Responsible for the writing of deviation and corrective/preventative action reports, as necessary. Responsible for the preparation of all media and sanitizing agents used in the Production areas. Running depyrogenation ovens and autoclaves. Perform all tasks adhering to company safety policies, including but not limited to bloodborne pathogen handling. Maintain supply inventory as directed by the production schedule. Responsible for proper operation of all clean room equipment.