Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Scientist leads cell culture and cell biology R&D activities supporting product innovation, design, testing and application development in cell therapy business. In addition, this position works in close collaboration with the cross-functional teams, research sites, customers and collaboration partners to develop new and support existing products & applications.
Establish, develop and optimize processes for cell therapy product development.
Innovative new product design, development, verification and validation.
Working with cross functional teams to develop Process & Product Validation plans / procedures.
Leverage broad cell biology expertise to help resolve urgent issues with current products.
Establish and execute protocols, SOPs and work instructions for the culture, expansion and harvest of immunotherapy relevant cells.
Design, develop and execute functional assays and QC methods for monitoring and characterizing cells.
Independent execution of practical experimental work and compliant recording/documenting of experimental methods, results, data analysis, conclusion and recommendations.
Active participation in global, cross functional project teams and execution of project activities to meet project milestones and timelines.
Interaction with customers, Product Managers, Application Specialists and Sales Specialists to understand customer needs and requirements.
Collaboration with both cross functional internal teams and external parties (academic groups, clinical and industrial partners) to deliver creative technical solutions.
Preparation and delivery of scientific papers and customer facing presentations (including presenting at international conferences).
Scientific & technical insight, guidance and support to customers and internal teams.
Communication effectively across the organization.
Generation of commercially relevant patentable ideas.
Continuously learn, grow and adapt in a fast moving field and monitor the cell therapy industry, market trends and technologies.
Evaluate and extend new concepts as well as deliver innovations which can be developed into new product advantages.
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Drive compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables 5. Champion continuous improvement activities by initiating process and product quality improvement initiatives
Master’s or Bachelor’s degree in cell biology, biology, bioprocessing, biotechnology, immunology or a related field.
5+ years’ relevant work experience including practical experience in cell therapy / regenerative medicine.
Demonstrated experience in working in fast paced, schedule driven projects to deliver high quality results.
Experience in sterile cell culture, analysis/characterization, process development. optimization techniques and handling clinical / blood samples in the isolation, preparation and culture of primary cells (preferably including T-Cells, TILS and NK cells).
Proven experience in writing scientific papers, technical presentations and posters
Excellent inter-personal communication and presentation skills and ability to gain buy-in for initiatives. Proven ability to collaborate and manage interactions with third parties to deliver results
Ph.D. degree in cell biology, bioprocessing, biotechnology, immunology or a related field.
Demonstrated problem solving ability and results orientation.
Demonstrated ability to deal with highly complex, ambiguous situations and drive clarity.
Demonstrated ability to lead small teams and influence broadly in a collaborative, matrixed, and customer focused environment
Experience in leading and influencing global cross-functional teams to achieve desired objectives.
Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
Demonstrated initiative and the ability to deliver high quality outcomes.
Experience in statistical design and analysis.
Familiarity with the applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as cGMP, ISO, or medical device development.
Locations: United States; Massachusetts; Marlborough
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