Job Description
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 performing routine and non-routine assays of raw materials, in-process samples, drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for product release and validation.
Schedule: This role requires onsite work from Tuesday to Saturday, emphasizing teamwork and collaboration.
Position Scope:
* Perform routine QC testing for raw materials, in-process, DP, and stability samples using equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, plate readers, etc., following SOPs and cGMP guidelines.
* Conduct cell culture, microbial, and molecular assays.
* Perform environmental monitoring and utilities testing.
* Carry out microbial limits, bioburden testing, and microorganism trending.
* Review QC data and prepare summaries for management.
* Report out-of-specification or out-of-trend results promptly to facilitate appropriate actions.
* Calibrate and maintain QC laboratory equipment, ensure laboratory housekeeping, and prepare for audits.
* Train less experienced staff members.
* Assist in transfer of methods from support groups to the QC laboratory.
* Coordinate departmental systems such as inventory, documentation, and equipment maintenance.
* Communicate effectively within and outside the department to resolve technical issues.
* Exercise sound judgment and decision-making in problem-solving scenarios.
* Review and update QC documents, including SOPs, protocols, and forms.
* Investigate deviations and laboratory issues.
* Maintain safe work habits and adhere to Vericel’s safety procedures.
* Perform other duties as assigned.
Qualifications:
* HS Diploma with 6+ years of industry experience in a cGMP lab environment or equivalent.
* Degree in microbiology, molecular biology, biochemistry, or related field; AS with 4-5 years’ industry experience or BS with 2+ years’ experience.
* At least 1+ years in cell culture, microbial, or molecular assays.
* Proficiency in Outlook, MS Word, Excel, and lab data management systems (LIMs).
* Experience with microbiological testing, biological assays, or environmental monitoring.
* Experience in biotech, pharmaceutical, or regulated industries.
* Knowledge of PCR methodologies or cell culture techniques.
* Advanced microbiological techniques, disinfectant efficacy testing, microbial identification, and rapid methods.
Why Vericel?
* Cutting-Edge Science: Work with leading regenerative medicine products that are transforming patient care.
* Career Growth: Opportunities to expand your impact within a growing organization.
* Collaborative Culture: Join a team passionate about improving lives.
EEO Statement
All applicants will receive consideration without regard to sex, gender, age, race, religion, national origin, veteran status, or other protected categories. Vericel is an Equal Opportunity/Affirmative Action Employer. We are a VEVRAA federal contractor prioritizing protected veteran referrals.
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