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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.

General Summary

Provide critical cellular therapy/regenerative medicine assay expertise to advance the development of QualTex Laboratories’ and BioBridge Global’s cellular therapy assay portfolio, which includes testing for viability, purity, potency, safety, and cell characterization. Responsible to manage, supervise and coordinate all scientific activities for QualTex Laboratories pertaining to cellular therapy/regenerative medicine product testing, including, new product or service development, qualification, validation, technical transfer, implementation, and training of Laboratory personnel on assays and relevant processes.

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.

It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards.

Major Duties and Responsibilities

Essential Tasks

Implementation and continuous improvement of cellular therapy/regenerative medicine product assays, which include, but are not limited to the following test methodologies: multi-color/multi-parameter flow cytometry, PCR, endotoxin, multiplex ELISA, bioassay, and potency assays.

Serve as a leader as well as work collaboratively with other scientists and technologists on projects in a

cross-functional team setting and act as a champion for cellular therapy assay product line.

Act as a liaison and forge collaborative relationships with internal and external QualTex and BioBridge Global clients, staff, suppliers, strategic partners, and regulatory/accreditation agencies.

Provide guidance to team-oriented work projects, and participate in the development and implementation of strategic initiatives.

Independently design, execute, and interpret results for laboratory experiments/validation studies to evaluate and/or validate laboratory processes and test methods, which may involve the implementation of highly complex testing machinery or manual testing skills.

Provide knowledge and expertise on relevant scientific principles, which may require authoring SOPs, supporting departmental training/competency assessment activities, participating in audits, and serving as a department liaison, as required.

Maintain adherence and assist with the development of project plans and budgets.

Establish operating parameters and quality control limits as required.

Assisting with the resolution of quality improvement investigations/CAPA implementation, equipment malfunctions and other technical problems.

Maintain strict adherence to Standard Operating Procedures (SOPs).

Prepare and maintain reports/records and perform computer data entry.

Performs other duties as assigned.

Non-Essential Tasks

Other duties as required.

Education

Requires a Master’s Degree from an accredited college or university in a specialized area, with no option for degree in related field or equivalent experience. The required major is Cellular Biology, Molecular Biology, Biochemistry, Cellular Engineering,

Prefer a Doctoral Degree (Ph.D. from an accredited college or university.)

Licenses and/or Certifications

Valid United States Driver’s License

US Passport preferred

Related Professional certifications preferred

Experience

Requires five or more years of job specific experience in regenerative medicine/cellular therapy testing, preferably in a cGMP and FDA regulated or clinical laboratory setting.

Requires the following technical skills/experience: aseptic technique, mammalian cell culture, flow cytometry, qPCR, multiplex ELISA, bioassay, potency assay, and microscopy.

Knowledge

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

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

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

Must have working knowledge of cell-based therapeutics and/or applied regenerative medicine and relevant product assays.

Skills

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

Must have excellent interpersonal and public speaking skills.

Must be capable of operating motor vehicles in all types of weather conditions.

Must have excellent hands-on laboratory skills.

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

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 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. 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, to include being on-call. Ability to use personal motor vehicle for company business required. 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 carry up to 25 lbs. and occasionally lift up to 40 lbs.

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. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. For more information about your EEO rights as an applicant under the law, please click here . BioBridge Global maintains a Tobacco & Drug-Free Workplace.