Associate I, Cell Therapy Manufacturing

Schedule

This position is onsite at our new Burlington, MA office, with some time required in our Cambridge office during the transition to the new facility. During the first 3–5 months of training, you will be onsite in Burlington Monday through Friday from 6:30 AM to 3:00 PM. Upon completion of training, you will transition to a shift schedule based on business needs, with current shifts being Sunday through Wednesday and Wednesday through Saturday, from 6:30 AM to 5:00 PM.

Key Responsibilities

• Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations.
• Qualified to perform aseptic manipulations of cell culture operations.
• Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
• Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs.
• Maintain manufacturing-controlled areas in an inspection ready state.
• Perform clean room equipment sanitization.
• Record equipment and facility metrology data to ensure the equipment operates within specifications.
• Report out of specification readings to production management.
• Able to work independently upon completion of training.
• Demonstrate the ability to organize, plan and manage time to effectively complete daily tasks.
• Be receptive to feedback and guidance from manager and other more experienced staff.
• Build and grow our teams through collaboration and positive interactions.
• The ability to cooperate with others in a team environment will be critical to your and our combined success.
• Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
• Assist in reviewing and revising production documents (SOP’s and electronic records).
• Ability to identify and report deviations and contribute to deviation investigations.
• In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, D365 ERP, TrackWise, Veeva.
• Other duties as assigned.

Basic Qualifications

• Bachelor’s degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 2+ years of cGMP experience.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.

Preferred Qualifications

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

Working Conditions & Physical Demands

• May be required to sit for long periods of time while performing cell culture operations.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day per week.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.