Associate II, Cell Therapy Manufacturing

Associate II, Cell Therapy Manufacturing

POSITION SUMMARY

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 a Manager, Cell Therapy Manufacturing 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.

Department Description:

Manufacturing of cell therapy products.

Position Summary:

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

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Master core responsibilities of a Manufacturing Associate I.
• Able to generate an effective production schedule.
• 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, TeamShare, QT.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

Leadership qualifications include, among other requirements:

• 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 a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Biotechnology certificate with 6+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or 8+ years of cGMP experience with GED or equivalent.
• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 4+ 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.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.

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