Manufacturing of cell therapy products.
The Manufacturing Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, Preactor), quality systems (deviations, change controls, CAPAs) and implementation of continuous improvement initiatives within the Manufacturing department.
- Coordinate and ensure successful completion of manufacturing projects
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Represent Manufacturing on cross-functional teams. Collaborate with other departments including QA, QC, Engineering, Validation, Material Management and Project Management.
- Assess process manufacturing performance by observation of the floor operations and review of performance data with the objective of implementing process improvement solutions.
- Lead investigations and provide troubleshooting for deviation reports.
- Assist in generation of training materials and may assist in providing training on technical aspects of the manufacturing process.
- Responsible for implementation of corrective actions.
- Assist with the execution of validation protocols.
- May participate in regulatory inspections.
- Participate in tech transfer activities; assess documentation, materials, training, procedures and systems modifications.
- Own changes or assist manufacturing change owner for changes impacting the process.
- Lead or participate on the assessment or implementation of special initiatives.
- May be required to support manufacturing operations during busy times
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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 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.
- 2-5 years of experience in a biopharmaceutical manufacturing environment.
- Familiarity with computer systems such as Preactor, GP, EBR and Trackwise.
- Must be familiar with biopharmaceutical equipment and systems
- Experience with cGMP Practices and regulatory requirements.
- Excellent communication skills, written and verbal.
- Organizational and planning skills and the ability to cooperate with others in a team environment.
- Experience with Microsoft Office.
- BA/BS in a scientific discipline or equivalent experience preferred.
- Basic laboratory skills, including working with mammalian cell culture
- Experience working in an ISO 7 cleanroom environment.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.
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.