Associate II, Cell Therapy Manufacturing

Vericel Corporation•Burlington, MA

16h•Onsite

About The Position

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). This position is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

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.
Experience with Microsoft Office suite.

Nice To Haves

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.

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, 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, OpCenter APS, 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.