Associate I, Cell Therapy Manufacturing

Vericel CorporationCambridge, MA, US

30+ days ago

Job type

Full-time

Job description

Job Description

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Manufacturing Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

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

DUTIES AND 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.
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. Be receptive to feedback and guidance from manager and other more experienced staff.
Ability to organize, plan and manage time to effectively complete daily tasks. 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.
Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
Assist in reviewing and revising production documents (SOP’s and electronic records).
Fully trained in at least one unit operation in both product lines.
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, GP, TrackWise, Veeva.
Achieve Qualified Trainer status.
Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

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 Biotechnology certificate with 1 – 2+ years of experience working in a cGMP environment in the biotechnology / pharmaceutical industry; or HS diploma / GED with 4 - 6+ years of cGMP experience.

Excellent communication skills, both written and verbal.

Experience with Microsoft Office suite.

Preferred Qualifications :

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 AND 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.

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.