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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!

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: Scientist II, Center for Innovations & Biodesign, Bioprocessing

Shift: Monday-Friday, 9am-5pm

FLSA: Exempt

Hybrid? N

Location: San Antonio

Dept.: Research & Development

Business Unit: BioBridge Global

General Summary

Responsible to provide high level support to BioBridge Research and Development group including supervising junior staff, leading technology transfer, GMP process and analytical methods development, managing laboratory safety programs, developing new assays and/or technologies as assigned by the department. Maintains knowledge of all current theories and principles required to effectively perform duties. Documents experiment results and prepare publications as needed. Trains others on newly developed assays. Maintains excellent communication with department and other laboratory services personnel. Demonstrates strict attention to detail, high quality customer service skills, team leadership skills and the ability to instill these qualities onto others on the team.

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

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

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 Center for Innovations and Biodesign, a part of BBG-R&D. Conduct, supervise assigned regenerative medicine‐related research and development.

Train and supervise junior staff and implement all relevant facility policies and procedures.

Design and perform experiments for bioprocess development, optimization, and characterization.

Conduct root-cause analysis for unexpected results and provide new approaches or experimental strategies for problem solving.

Conduct detailed in vitro characterization of cell therapy products using protein and gene expression analysis.

Design and conduct experiments for individual bioprocess unit operations using relevant operational parameters and analytical inputs.

Contribute to the development of next generation of new products, cell manufacturing and process engineering platform.

Support internal product improvement efforts by providing biological performance data using bioreactors. Serve as Subject Matter Expert (SME) for bioprocessing.

Design and execute experiments to drive innovative technology and platform evaluation for next generation advanced therapies and work collaboratively with downstream process development and analytical development teams.

Execute adherent and suspension small-scale bioreactor-based cell culture processes for manufacturing of gene therapy vectors across multiple programs and disease areas to ensure on time delivery on goals.

Collaborate with and participate in cross-functional teams to facilitate IND-enabling, clinical Phase I/II-enabling activities as well as BLA enabling workstreams.

Design and execute plans for method qualification per ICH and regulatory guidelines. Experience in cellular mechanism of action.

Cell therapy upstream process development and analytics, including product characterization, process parameter optimization, and single‐use bioreactors.

Design impellers for bioreactors using computational fluid dynamics approach.

Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners.

Expertise with existing and emerging systems in this space together with troubleshooting is required.

Data analysis using FlowJo, and GraphPad.

Work with internal and external partners to test, optimize and advance new cellular therapies into early development and Phase 1 clinical trials.

Regularly report back to supervisor on the progress of work. Summarize and present results to supervisor in a logical manner, verbally and in written reports.

Present work at group and departmental meetings; contribute to the drafting of protocols, method development reports, and peer‐reviewed publications.

Possess the desire and ability to work in a team environment under limited supervision.

Contribute to lab and equipment maintenance and order supplies/reagents to help create a safe, effective and efficient working environment.

Analyze, interpret, and present data, troubleshoot experiments, and provide an accurate summary to the management.

Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development tomaximize capacity and reduce cost of goods.

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).

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.

Always maintain a professional demeanor while representing BBG‐R&D. Performs other duties as assigned.

Performs other duties as assigned.

Non-Essential Tasks

Assist in other laboratory areas as directed.

Education

Requires a thesis-based Master's Degree from an accredited college or university. The required major is bioengineering, biotechnology, bioprocessing, or chemical engineering.

Prefer a Doctoral Degree (e.g., Ph.D or equivalent) from an accredited college or university. The required major is bioengineering, biotechnology, bioprocessing, or chemical engineering.

Licenses and/or Certifications

Valid United States Driver’s License

US Passport preferred

Experience

If Master's Degree is attained, requires three years of related industry post-graduation experience.

If Ph.D is attained, requires one year of related industry post-graduation experience.

Requires one or more years of related academic experience.

Requires hands-on experience with pluripotent stem cell, mesenchymal stem cell, T cell or NK cell expansion using bioreactors.

Requires prior experiences developing novel upstream process for extracellular vesicles, recombinant proteins and antibodies or early-stage viral vector manufacturing.

Requires expertise in upstream processing techniques in mammalian cell expansion pertinent to cell and gene therapy.

Requires knowledge of bioreactors and process control, cell characterization methodology such as cell counting, metabolic analysis, and Design of Engineering approach (DoE).

Prefer one year of related experience.

Prefer experiences in operating stirred-tank bioreactors for adherent and suspension cell cultures.

Prefer experiences in operating stirred-tank bioreactors for microbial and mammalian cell cultures Prefer cellular therapies‐related product development experience.

Prefer a background in cGMP principles and Quality Management Systems as well as experience in a GMP manufacturing and/or Quality Control testing environment.

Prefer applied research and product development experience.

Prefer expertise in closed‐system process development.

Prefer experience with multivariate data analysis, predictive analytics, and machine learning.

Prefer multivariate or machine learning data analytics experience (eg; JMP, python, R).

Prefer working knowledge of T cell, NK-cells, CAR-M metabolism and/or assays.

Knowledge

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

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

Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).

Must have a working knowledge of bioprocessing techniques.

Must have a working knowledge of bioreators used in cell and gene therapies.

Must have a specific understanding of two or more of the following subject matter areas is strongly preferred: design of engineering (DoE), bioreactors design principles, upstream processing, multi-variate analytics.

Skills

Must have excellent written and oral communication skills.

Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions. Must have excellent interpersonal and public speaking skills.

Must have strong computer skills.

Must have exceptional communication and networking skills.

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

Must maintain competency in laboratory skills for liquid and material handling.

Must have basic library and literature-based research skills.

Abilities

Must be a self-starter and self-directed worker.

Must be able to conduct experiments and correctly interpret results.

Must be able to keep information confidential.

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

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 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 perform well in repetitive work situations.

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.

Physical Requirements

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. Must be able to drive on behalf of the organization.

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