The Research and Development group within Vericel supports the continuing development, characterization and validation of manufacturing methods, novel assays, new technology and operational improvements. This group manages technology transfers, clinical manufacturing, training, database development, trending analysis and stability. The R&D team plays an important role in commercial manufacturing troubleshooting, root cause investigation, process optimization and product life cycle management.
Performs complex experimental procedures and assays using established techniques. Investigates and troubleshoots basic technical problems. Integrates compiles and tabulates data, assist in review, analysis and interpretation of results.
- Work independently to perform experiments and analytical procedures related to the site's product development. Approach is mainly supervisor directed.
- Perform culture of human autologous cells, cell based assays, qPCR, and ELISA to support ongoing studies for process development, process improvement, and process validations.
- Plan and prioritize concurrent experimental procedures, tabulate, analyze and present data, as well as investigate technical problems.
- Support manufacturing process development by performing analytical testing for the characterization of reference strain banks/cell banks.
- Develop analytical methods for use in GMP environment, support technical transfers to QC group as well as provide technical guidance and training to less experienced staff.
- Perform culture of autologous cells, cell and molecular based analytical test methods to support process development.
- Provide data review and analysis, compile and communicate results to supervisor and entire group.
- Draft technical protocols and compile technical reports. Maintain lab notebook entries.
- Participate in routine lab maintenance activities and media/material ordering.
- Perform internal safety audits of the laboratory.
- Provide oral presentations on work progress across multi-functional teams.
- Maintain operational and safe working environment in accordance with BL-2 standards.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- 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.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- BS degree or equivalent with 3+ years of work experience.
- MS degree or equivalent with 1+ years of work experience.
- Experience with cell culture and molecular and cell biology techniques.
- Experience in analyzing, troubleshooting and interpreting test results, and providing recommendations for method improvement.
- Effective communication skills both written and oral.
- Ability to multitask.
- Prior experience with internal and external method transfers and Current Good Manufacturing Practices (cGMPs).
- Experience in authoring analytical procedures for execution of testing, cross training, and method transfer.
- Experience/familiarity with cell culture, qPCR, ELISA, cell based assays.
- Experience/familiarity with histological staining and biochemical analysis.
- Experience/knowledge on tissue engineering and regenerative medicine.
All qualified 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 Employer.