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.
Applies scientific and/or engineering principles and expertise in the design and development of robust, cost-effective manufacturing procedures and associated analytical method that meet quality, GMP, regulatory and health, safety, and environmental standards.
- Demonstrates a comprehensive solid understanding and use of scientific / engineering principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
- Leads design reviews, cross-functional development teams and provides scientific / engineering support and guidance in the development, scale-up, optimization and operation of methods for the production and testing of new components, technologies and products.
- Maintains and demonstrates significant knowledge of state-of-the art principles and theories in area of responsibility.
- Independently reviews existing process and analytical development and production data; designs and conducts necessary experiments; interprets results; recommends changes or additional experiments.
- Designs, executes, and interprets experiments to identify new methods to enhance the manufacture of or characterization of products in regard to safety, identity, strength, purity, stability and quality with minimal direction.
- Stay abreast of new developments/technologies in areas of responsibility. Prepares proposals for introduction of technologies outlining the positive impact to the product for cost and/or quality.
- Participate in establishing project strategy in consultation with management.
- Represents the corporation in the greater biotech community by publishing in peer review journals and participation in scientific / technical conferences.
- Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
- Guides the successful completion of major programs and may function in a project leadership role.
- Directs the work of more junior staff. Provides technical guidance and trains less experienced staff.
- Other duties as assigned.
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 and 9+ years of related work experience, or
- MS and 7+ years of related work experience, or
- Ph.D. or equivalent in Biology, Biochemistry, Biomedical, Chemical, or Mechanical Engineering, or related fields and 4+ years of related work experience.
- Expertise in one or more of the following: Bioengineering, Molecular Biology, Flow Cytometry.
- Advanced expertise in mammalian cell culture and related techniques.
- Proficient with technical writing and statistical analysis to produce technical and/or validation protocols and reports.
- 4+ years of experience working on development or support of assays and/or manufacturing processes for a biological drug in a GMP facility.
- 4+ years of experience in isolation and culturing human primary cells.
- 4+ years of experience in developing autologous cell therapies or tissue engineered products.
- Hands-on analytical experience using techniques such as RNA/DNA purification, PCR, qPCR, multi-color flow cytometry, cell counting, and cell-based assays.
- Experience designing primers and probes for qPCR and gene expression analysis.
- Advanced expertise in product, process and test method development as well as mechanical design, prototyping, biomaterials.
- Technical ability to turn design ideas into product/process improvements.
- Proficient in CAD software, preferably AutoCAD and MATLAB
- Good leadership and people skills, teamwork experience, and demonstrated conflict handling and resolution ability and negotiation skills.
- Good achievement and record in scientific research and technical development as evidenced by research paper, conference presentation, and patent publications.
- Self-motivated, organized, familiar with the relevant literature, attention to details.
Posting ID: 595024465Posted: 2021-02-28