Scientist II, Cell & Tissue Reference Laboratory

Our organization is unique in that we are a nonprofit community resource that saves lives by working with volunteer donors to provide the highest quality blood & tissue components to patients. By using cutting-edge technology, our team of dedicated professionals has helped save hundreds of thousands of lives for more than 35 years. Over 200,000 components of life-saving blood and tissue from volunteers throughout South Texas are collected and tested each year. We are internationally recognized for the quality of our services and research. Donors are essential because patients are in constant need of blood. blood components, and/or tissue. It's about life! Share our excitement and join our team!

QualTex Laboratories, a subsidiary of BioBridge Global, is one of the largest independent non-profit testing laboratories in the United States for blood and plasma products. QualTex Laboratories is dedicated to supporting global public safety with the timely delivery of high-quality testing services for patients, donors and regulated biological products.

Job Title: Scientist II, Cell & Tissue Reference Laboratory

Shift: M-F 09:00-17:00; occasional evenings and weekends

Location: San Antonio

Dept.: Cell & Tissue Reference Laboratory

Business Unit: QualTex‐SA

General Summary
Provide critical cellular therapy/regenerative medicine assay expertise to advance the development of QualTex Laboratories' 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, validation, 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 (including donors) through established 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 21 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, ELISA.

Serve as a leader 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 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 in order 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. The required major is Cellular Biology, Molecular Biology, Biochemistry, Cellular Engineering, or a related field.

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/FDA regulated or clinical laboratory setting.

Requires the following technical skills/experience: aseptic technique, mammalian cell culture, flow cytometry, PCR, ELISA, microscopy.

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

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 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 required.

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

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

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 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.

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:

• Variable Compensation Plan

• 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 w/prescription coverage

• Paid Holidays

• Variety of Voluntary Supplemental Insurances

• Leaves of Absence

• Voluntary Dental Coverage

• Educational Assistance Program

• Voluntary Vision

• 401k Plan

• Competitive salary

QualTex Laboratories, a subsidiary of BioBridge Global, is 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 click here. QualTex Laboratories maintains a Tobacco & Drug-Free Workplace.