Associate II, Cell Therapy Manufacturing

Job Description

Job Description

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary:

The Associate II, Cell Therapy Manufacturing will be responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

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.

Position Scope:

• 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, demonstrated proficiency in organizing, time management and collaboration within the team to deliver the Manufacturing Team’s daily tasks. Be receptive to feedback and guidance from manager and other more experienced staff.
• Ability to organize, plan and manage time effectively to complete daily tasks. 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.
• Perform transactions in ERP system.
• 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, train and qualify in at least three core competencies,e.g.3T3, Media Prep, D365 ERP, TrackWise, OpCenterAPS, Veeva, Qualified Trainer Or achieve qualified status in at least three operations in both product lines.
• Assists in balancing workload by picking up work from others as necessary. Able to assist in generating an effective production schedule and communicate changes with peers for alignment.
• Be recognized for your consistency and proficiency on our Manufacturing Operations.
• Assist Training team in mentoring junior staff. Performs cross training and process observations to support team-wide activities.
• Other duties as assigned.

Basic Qualificatio ns:

• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 1+ Years of experience with Vericel operations with demonstrated team-focused behaviors or 2+ years of
  external experience working in a cGMP environment in the biotechnology or pharmaceutical
  industry.
• HS diploma/GED or equivalent with 3+ Years of experience with Vericel operations with demonstrated team-focused behaviors or 4+ years of cGMP experience.
• Excellent communication skills, written and verbal.
• Strong leadership skills; recognized by peers as a leader.
• Experience with Microsoft Office suite.

Preferred Qualificatio ns:

• 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.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $28.00 to $31.25 per hour.

The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.