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.
Maintain a safe, efficient, functional and compliant cGMP laboratory according to regulatory, site and corporate guidelines.
Oversee day-to-day operations that include cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, cell banks following respective procedures.
Support of our clinical and commercial AAV-based products.
Author reports, Standard Operating Procedures (SOPs), and other documentation for quality testing and equipment.
Provide training and technical leadership to less experienced staff members.
Support method validation and analytical technology transfer activities partnered with QC Technical Services and QA.
Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance and CAPA including.
Participate in or conduct laboratory investigations and address non-conformance deviations.
Perform finished product reviews and oversee lot releases.
Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
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 0-3 years of relevant industry experience in a CGMP lab environment, or equivalent.
Master’s Degree with a minimum of 2-5 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, Change Control, Data Review, and CAPAs.
Proficiency with complex analytical methods, such as PCR-based methodologies or cell culture techniques.
Experience with assay/equipment validations and transfers.
Cell culture experience (human derived cell lines) is required
Experience within Bioanalytical/Bioassay/Virology
Excellent verbal and written communication skills.
Strong technical writing and investigational abilities.
