This senior scientist role involves managing and coordinating all scientific activities within the Research & Development department, focusing on applied research, new product/service development, clinical trials, and data analysis. The position also includes managing the Applied Regenerative Medicine Laboratory and requires a commitment to BioBridge Global's core values.
Responsibilities
Manage and coordinate all scientific activities for BBG-R&D
Conduct, supervise assigned regenerative medicine-related research and development, including analytical assays
Train and supervise junior staff and implement all relevant facility policies and procedures
Manage and coordinate all research, early new product and/or service development, and specialty projects, including any clinical-trial support and Investigational New Drug (IND) studies
Assist in managing the BBG-R&D lab
Perform literature searches and hands-on laboratory investigation in support of product and/or service development
Spearhead new product development of tissue engineered products and solutions
Work with internal and external clients to set Target Product Profile (TPP) and Critical Quality Attributes (CQA) for new products and services
Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development to maximize capacity and reduce cost of goods
Coordinate and maintain alignment of investigative activities with other subsidiaries
Lead and/or assist in technology transfer, GAP analysis, and industrialization of process
Responsible for troubleshooting, deviation investigation, and product impact assessment for projects
Organize and prioritize work to meet timelines and ability to execute on multiple projects
Apply for appropriate grants and studies relevant to regenerative medicine
Design and develop cGLP documentation for generation and maintenance of a stable human-derived stem cell line
Expand and differentiate xeno-free human-derived stem cells
Develop and conduct lineage-specific functional assays for stem cells and extracellular vesicles
Expand, differentiate and cryopreserve stem cells
Isolate, process and characterize extracellular vesicles and cryopreservation
Perform analytical method development and testing
Responsible for publication of abstracts and papers for BBG-R&D
Evaluate and/or develop new product and service offerings and make recommendations for improvement to existing BBG-R&D offerings
Responsible to assure that all BBG-R&D equipment are performing within specifications
Collaborate and work effectively with other industry leaders, internal and external BBG-R&D clients, staff, suppliers, and regulatory agencies
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Participate in regional, national, and international scientific forums on behalf of BBG-R&D
Provide guidance to team-oriented work projects for the development and implementation of strategic initiatives - validations, process improvements, and Standard Operating Procedures (SOPs)
Participate in executive team strategic planning and business plan execution
Participate in internal and external audits/inspections
Utilize performance excellence principles by using data and facts to plan and make decisions
Ensure that organizational goals/strategic objectives are converted to appropriate actions to align work
Measure and monitor progress toward achieving the goals/strategic objectives
Display positive leadership skills and champion strategic and management directives with department staff by committing to and embracing the mission, vision, and core values of BBG-R&D
Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements
Foster an atmosphere of open, honest communication and knowledge sharing among workers in business units throughout the organization
Demonstrate respect for co-workers and management
Consistently improve performance outcomes in customer satisfaction, worker engagement (motivation and satisfaction), operational excellence, innovation, and financial performance
Maintain a positive work attitude and participate in self-improvement as an effective leader
Always maintain a professional demeanor while representing BBG-R&D
Perform duties of the management under your supervision during their absences
Provide world-class customer service by capturing and being responsive to the voice of the customer through multiple feedback channels
Resolve issues and drive satisfaction in accordance with BBG customer engagement, feedback, and complaint processes
Requirements
Doctoral Degree (e.g., Ph.D., M.D., O.D., or equivalent) from an accredited college or university
Five or more years of relevant life science experience
Ability to correctly interpret process outcomes
Working knowledge of laboratory and research systems
Knowledge of on-line research tools and databanks
Knowledge of and perform according to Standard Operating Procedures (SOPs) and policies
Familiarity with regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
Working knowledge of laboratory sciences and techniques
Ability to recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work
Excellent hands-on laboratory skills
Strong computer skills
Ability to solve technical and/or clinical problems with biotechnology-based solutions
Capable of evaluating, interpreting, and reporting accurate/valid test results by current testing methodologies
Excellent interpersonal and public speaking skills
Ability to keep information confidential
Neat in appearance and well groomed
Ability to work with interruptions, meet deadlines, and perform accurate laboratory testing
Energetic, enthusiastic and have a team-oriented leadership style
Professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently
Perform well in repetitive work situations
Ability to conduct experiments and correctly interpret test results
Ability to work independently as well as in a team environment
Nice to have:
Three or more years of management/leadership experience
Regenerative medicine applied research and product development experience
Regenerative medicine-related assay development experience
Hands-on experience with flow, PCR, mass spectroscopy and cell-based potency assays
In vivo model product performance testing experience
Important Details
Occupational Exposure Assignment: Category I
About the Company
BioBridge Global is committed to its Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).
