Senior Scientist
Company: Vericel
Location: Cambridge
Posted on: May 14, 2022
Job Description:
Job DescriptionPOSITION SUMMARYDepartment Description: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. Position
Summary: Applies scientific 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.ESSENTIAL
FUNCTIONSCore Responsibilities:
- Demonstrates a comprehensive solid understanding and use of
scientific principles and professional practices, to solve a wide
range of complex problems in creative and practical ways.
- Leads cross-functional development teams and provides
scientific 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 regards 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.QUALIFICATIONS, EDUCATION AND
EXPERIENCELeaderships Qualifications: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.Basic
Qualifications:
- BS and 10+ years of related work experience, or
- MS and 8+ years of related work experience, or
- Ph.D. or equivalent in Biology, Biochemistry, Biomedical
engineering, Pharmaceutical Sciences or related fields and 6+ years
of related work experience.
- Advanced expertise in mammalian cell culture and related
techniques.
- Familiarity with technical writing and statistical analysis to
produce research protocols and reports.Preferred Qualifications:
- 6+ years of experience working on development or support of
assays and/or manufacturing processes for a biological drug in a
GMP facility.
- 6+ years of experience in isolation and culturing human primary
cells.
- Experience with medium development, cell banking methods and
development of cell-based assays.
- 2+ years of experience in developing autologous cell therapies
or tissue engineered products.
- Extensive hands-on experience in analytical methods for
protein, RNA and DNA analysis.
- Prior experience in cGMP environment and clean room
requirements.
- Prior success with cell-based assay development.
- Good leadership and people skills, team work 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.
Keywords: Vericel, Cambridge , Senior Scientist, Other , Cambridge, Massachusetts
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