Associate II, Cell Therapy Manufacturing

About the role

The Associate II, Cell Therapy Manufacturing will execute process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. The position is onsite at our new Burlington, MA office with some time required in our Cambridge office during the transition.

Responsibilities

• Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations.
• 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.
• Work independently, demonstrate 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.
• Able to work effectively, organize, plan and manage time effectively to complete daily tasks.
• Build and grow our teams through collaboration and positive interactions.
• 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.
• 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.
• Able to assist 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.
• Perform cross training and process observations to support team-wide activities.
• Other duties as assigned.

Requirements

• 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.

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.

Skills

• Hands-on laboratory experience.
• Experience with Microsoft Office suite.
• 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.

Benefits

Vericel Corporation offers a competitive hourly wage range of $28.00 to $31.25 per hour, with the actual salary determined based on factors such as qualifications, experience, and skills. Bonus, incentive pay, equity, and benefits may be provided in addition to the base compensation listed above.

Pay

Vericel Corporation's hourly wage range for this position 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.

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.

Why Vericel?

Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. We are committed to innovation, patient-centered focus, and scientific excellence, driving the development of groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

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.