Senior Associate, Cell Therapy Manufacturing

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:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

Schedule:

This position is onsite 5 days a week in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility. The two available shifts are Sun-Wed or Wed-Sat.

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.

* Demonstrated proficiency in organizing small groups and teams, to deliver key initiatives and small projects.

* Effectively use time management and collaboration across the team to seek out opportunities to ensure delivery of the Manufacturing Team's daily tasks.

* Work with influence and rapport across the Team. Be receptive to feedback and guidance from manager and other more experienced staff.

* Build and grow our teams through collaboration and positive interactions. Demonstrated influence and leadership qualities, to directly support the Team Leads. The ability to cooperate with others in a team environment will be critical to 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, lead GEMBA interviews and contribute to deviation investigations.

* In addition to being fully qualified in MACI or Epicel manufacturing process, cross train and qualify in at least 5 core competenciese.g.3T3, Media Prep,D365 ERP, Track Wise, Veeva.

* Achieve and maintain approved Qualified Trainer status for at least 3 Operations. Be receptive to feedback and coaching on your presence and methods for training, as well as support efforts to drive consistency and standardization on operational methodology.

* Serve as a technical resource for questions and /or investigate manufacturing issues.

* Collaborate with Production Planners to ensure schedule accuracy

* Communicate patient lots status with Customer Care team

* Other duties as assigned.

Basic Qualifications:

* Bachelor's or higher degree (Life Sciences or related field) or equivalent with3+years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or 4+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.

* HS Diploma/GED with 4+ Years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or with 5+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.

* 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.

Why Vericel?

* Cutting-Edge Science:
Work with a leading regenerative medicine product that is transforming patient care.

* Career Growth:
Be a…