Senior Technician, Cell Therapy Manufacturing

Vericel Corporation•Burlington, MA
•Onsite

About The Position

The Senior Technician, Cell Therapy Manufacturing executes process steps to manufacture commercial cell therapy products in accordance with internal and regulatory requirements. The role performs manufacturing procedures in a clean room, including aseptic cell-culture operations, and makes cell-culture decisions based on observations and written procedures. It also involves accurate cGMP documentation, maintaining controlled areas and equipment in an inspection-ready condition, recording equipment and facility metrology data, and reporting out-of-specification readings. The position is onsite in Burlington, Massachusetts, with some time in Cambridge during the facility transition. The first 3–5 months are training onsite Monday through Friday, 6:30 AM–3:00 PM. After training, the technician transitions to a business-needs-based schedule; current shifts are Sunday through Wednesday or Wednesday through Saturday, 6:30 AM–5:00 PM. The role requires the ability to work one weekend day per week and provide rotating holiday coverage. The hourly wage range is $21–$25. Bonus, incentive pay, equity, and benefits may also be provided. Vericel describes its work as advanced cell therapies for sports medicine and severe burn care, including MACI, Epicel, and Nexob​​rid.

Requirements

  • Associate’s degree, or high school diploma/GED or equivalent with 0–1 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.
  • Excellent written and verbal communication skills.
  • Experience with the Microsoft Office suite.
  • Ability to work one weekend day per week.
  • Ability to provide rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.
  • Ability to sit for long periods while performing cell-culture operations.
  • Ability to lift, carry, push, and pull up to 50 pounds.

Nice To Haves

  • Biotechnology certificate that includes hands-on laboratory courses.
  • Experience in small-scale tissue-culture processing.
  • Experience working in a regulated environment that is frequently audited by internal and external agencies, such as the FDA and ISO.

Responsibilities

  • Perform manufacturing procedures in a manufacturing clean room according to established SOPs, cGMPs, and safety regulations.
  • Perform qualified aseptic manipulations in cell-culture operations.
  • Make cell-culture decisions based on cell observations and guidelines in written procedures.
  • Document operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs.
  • Maintain manufacturing-controlled areas in an inspection-ready state.
  • Sanitize clean-room equipment.
  • Record equipment and facility metrology data to ensure equipment operates within specifications.
  • Report out-of-specification readings to production management.
  • Work independently upon completion of training.
  • Organize, plan, and manage time to complete daily tasks effectively.
  • Receive feedback and guidance from the manager and experienced staff.
  • Collaborate and interact positively with the team.
  • Practice safe work habits and follow Vericel safety procedures and guidelines.
  • Assist in reviewing and revising production documents, including SOPs and electronic records.
  • Perform other duties as assigned.

Benefits

  • Bonus, incentive pay, equity, and benefits may be provided in addition to base compensation.
  • Career growth opportunities in a growing organization.
  • Collaborative culture.
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