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BioBridge Global is a San Antonio-based nonprofit, that integrates donor-to-patient services to enable the future of biotherapeutic solutions, including blood, tissue, and advanced therapies. Through our subsidiaries – South Texas Blood & Tissue, QualTex Laboratories and GenCure – we provide products and services in blood resource management, cellular therapy manufacturing, donated umbilical cord blood and human tissue, as well as testing of blood, plasma, tissue, and cellular products for clients in the United States and international markets. We also support the development advanced therapies by providing access to starting materials, testing services, biomanufacturing of cell and cell-based biologics and clinical trials support.

We at BioBridge Global have been committed to saving and enhancing lives through the healing power of human cells and tissue for over 50 years. If you share our passion, join our team!

BioBridge Global (BBG) (http://biobridgeglobal.org/subsidiaries) is a non-profit company that oversees and supports South Texas Blood & Tissue Center (STBTC), QualTex Laboratories, GenCure, and The Blood and Tissue Center Foundation. For over 40 years, our team of dedicated professionals has made life-saving connections. Our diverse services bridge critical medical industry needs with innovative solutions.

Job Title: Senior Scientist, Research & Development

Revision: 0002

Job Code: 703774

Shift: Monday-Friday, Day Shift

FLSA: Exempt

Hybrid? N

Dept.: Research & Development

Business Unit: BioBridge Global

CPF Level: P6

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.

Performs other duties as assigned.

Non‐Essential Tasks

Perform duties of the management under your supervision during their absences.

Education

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

Licenses and/or Certifications

Valid United States Driver’s License US Passport preferred

Professional certifications preferred

Experience

Requires five or more years of relevant life science 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 withflow,PCR, mass spectroscopy and cell‐based potency assays is a plus. In vivo model product performance testing experience preferred.

Knowledge

Must have a specific understanding of two or more of the following subject matter areas: wound healing biology, bone biology, cell‐based therapeutics and/or applied regenerative medicine.

Must have a working knowledge of tissue and cell culture.

Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

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

Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations.

Skills

Must have excellent hands‐on laboratory skills.

Must demonstrate the ability to solve technical and/or clinical problems with biotechnology‐based solutions. Must be capable of operating motor vehicles in all types of weather conditions.

Must have excellent written and oral communication skills. Must have excellent interpersonal and public speaking skills.

Abilities

Must be able to commit to project delivery timelines and budget.

Must be able to keep information confidential.

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

Must be neat in appearance and well groomed.

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

Must have ability to multi‐task by handling multiple projects while simultaneously advancing writing grant proposals, and documentation.

Must maintain a good working rapport with co‐workers.

Working Environment

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. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend.

Occupational Exposure Assignment‐Category I

Physical Requirements

Must be able to drive on behalf of the organization. Will sit, stand, walk, and bend during working hours.

Requires manual and finger dexterity and eye‐hand coordination. Required to lift and carry relatively light materials.

Requires normal or corrected vision and hearing corrected to a normal range.

We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!

All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:

• Competitive salary

• 100% Employer Paid Life Insurance

• 401(k) with Employer Contribution

• 100% Employer Paid Long-term Disability Plan

• Paid Time Off (PTO)

• 100% Employer Paid AD&D

• Extended Illness Benefits (EIB)

• 100% Employer Paid Employee Assistance Program

• Shift Differentials

• Group Health Medical Plan with prescription coverage

• Paid Holidays

• Variety of Voluntary Supplemental Insurances

• Incentive Compensation Plan

• Voluntary Dental Coverage

• Educational Assistance Program

• Voluntary Vision

BioBridge Global and its subsidiaries are proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please clickhere (http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf) . BioBridge Global maintains a Tobacco & Drug-Free Workplace