Senior Scientist, Research & Development at BioBridge… · San…

General Summary Responsible to manage, supervise and coordinate all scientific activities for BBG-R&D including applied research, early new product or service development, clinical trials/translational research, data collection, analysis, and scientific publication. Manage the BBG-R&D Applied Regenerative Medicine Laboratory (BBG-R&D).

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks

• Responsible for the performance of research projects, whether performed personally or delegated.

• 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 a stable human-derived stem cell line. Expansion and differentiation of xeno-free human-derived stem cells. Develop and conduct lineage-specific functional assays for stem cells and extra cellular vesicles. Expansion, differentiation and cryopreservation of stem cells. Isolation, processing and characterization of extracellular vesicles and cryopreservation. Analytical method development and testing.

• Responsible for publication of abstracts and papers for BBG-R&D and the 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.

• 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.

• Demonstrate utilization of performance excellence principles by: Using data and facts to plan and make decisions. Ensuring that organizational goals/strategic objectives are converted to appropriate actions to align work. Measuring and monitoring 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.

Performs other duties as assigned.

Non-Essential Tasks

Education

Required Minimum Education Requires a Doctoral Degree (e.g., Ph.D., M.D., O.D., or equivalent) from an accredited college or university. Preferred Education

Licenses and/or Certifications

Experience

Required Minimum Experience

• Requires five or more years of relevant life science experience. Preferred Experience

• Prefer three or more years of management/leadership experience.Regenerative medicine applied research and product development experience strongly preferred.Regenerative medicine-related assay development experience preferred. Hands-on experience with flow, PCR, mass spectroscopy and cell-based potency assays is a plus.In vivo model product performance testing experience preferred. Experience Exception to Education

Knowledge

• Must be able to correctly interpret process outcomes.

• Must have a working knowledge of laboratory and research systems.

• Must maintain knowledge of on-line research tools and databanks.

• Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.

• Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.

• Must have a working knowledge of laboratory sciences and techniques.

• Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.

Skills

• Must have excellent hands‐on laboratory skills.

• Must have strong computer skills.

• Must demonstrate the ability to solve technical and/or clinical problems with biotechnology‐based solutions required.

• Must be capable of evaluating, interpreting, and reporting accurate/valid test results by current testing methodologies.

• Must have excellent interpersonal and public speaking skills.

Abilities

• Must be able to keep information confidential.

• Must be neat in appearance and well groomed.

• Must be able to work with interruptions, meet deadlines, and perform accurate laboratory testing.

• Must be energetic, enthusiastic and have a team-oriented leadership style.

• Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.

• Must perform well in repetitive work situations.

• Must be able to conduct experiments and correctly interpret test results.

• Must be able to work independently as well as in a team environment.

Working Environment & Travel Requirements

Works in a well-lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. May be required to work any time of the day, evening or night during the week or weekend. Occupational Exposure Assignment - Category I Travel Requirements

Physical Requirements

Physical Requirements Will sit, stand, walk, and bend during working hours. Requires to reach, lift and carry up to 20 lbs Required to lift and carry relatively light materials. Requires normal or corrected vision and hearing corrected to a normal range.