Senior Technician, Cell Therapy Manufacturing

Vericel® Corporation•Burlington, MA

5d•$21 - $25•Onsite

About The Position

At Vericel Corporation, a company focused on advanced cell therapies for sports medicine and severe burn care, the Senior Technician, Cell Therapy Manufacturing executes process steps to manufacture commercial cell therapy products in accordance with internal and regulatory requirements. The role is onsite at the new Burlington, Massachusetts office, with some time in the Cambridge office during the facility transition. The initial 3–5 months of training take place onsite in Burlington, Monday through Friday from 6:30 AM to 3:00 PM. After training, the employee transitions to a shift schedule based on business needs. Current shifts run Sunday through Wednesday or Wednesday through Saturday, from 6:30 AM to 5:00 PM.

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 extended 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 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 and sanitize clean-room equipment.
Record equipment and facility metrology data, ensure equipment operates within specifications, and report out-of-specification readings to production management.
Work independently after training and organize, plan, and manage time to complete daily tasks.
Receive feedback and guidance from the manager and experienced staff.
Collaborate and interact positively with teammates in a team environment.
Follow safe work habits and Vericel’s safety procedures and guidelines.
Assist in reviewing and revising production documents, including SOPs and electronic records.
Perform other duties as assigned.