Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
DUTIES AND RESPONSIBILITIES
Essential Functions: • Master core responsibilities of an Associate I, Cell Therapy Manufacturing. • Able to assist in generating an effective production schedule. • Able to redistribute assignments on the production floor based on changes to the schedule and/or resource availability. • In addition to being fully qualified in MACI or Epicel, train and qualify in at least three core competencies, e.g. 3T3, Media Prep, GP, TrackWise, Preactor, Veeva, QT. • Other duties as assigned.
Leadership Responsibilities: • Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics • Being honest and treating people with respect and courtesy. • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products. • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications: • Biotechnology certificate with 2 - 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or GED or equivalent with 6 - 8+ years of cGMP experience • Bachelor's or higher degree (Life Sciences or related field) or equivalent with 1 - 2 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: • 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.