Job Responibilities:

• Conduct microbiological, molecular, and cell culture assays for both in-process and final product samples.
• Assist in transferring methodologies from other groups and may manage complex equipment.
• Author reports, Standard Operating Procedures (SOPs), and other documentation for quality testing and equipment.
• Provide training and technical leadership to less experienced staff members.
• Participate in or conduct laboratory investigations and address non-conformance deviations.
• Perform finished product reviews and oversee lot releases.
• Potentially manage departmental projects.
• Participate in the execution of corrective and preventative action plans, as well as initiate and follow through with change controls.
• Exercise judgment and decision-making skills to solve problems.
• Communicate with other departments and external contacts to resolve technical issues.
• Perform other duties as assigned.
• Adhere to and promote the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Demonstrate honesty and respect in all interactions.
• Strive to make Vericel a great place to work, earning respect for the quality of its people and products.
• Act as role models for fellow employees and business partners by behaving responsibly, fairly, and honestly, and exercising sound judgment in job performance.

Qualifications:

• Bachelor’s Degree with a minimum of 5 years of relevant industry experience in a CGMP lab environment, or equivalent.
• Master’s Degree with a minimum of 3 years of relevant industry experience in a CGMP lab environment, or equivalent.
• Proven experience as a technical leader in a strong team environment and the ability to work independently to balance short and long-term project objectives successfully.
• Experience with Deviation Management and Change Control.
• Proficiency with complex analytical methods, such as PCR-based methodologies or cell culture techniques.
• Experience with assay/equipment validations and transfers.
• Excellent verbal and written communication skills.
• Strong technical writing and investigational abilities.