Job Title: Scientist II, Center for Innovations & Biodesign, Immunology 

Revision: 0000

Job Code: 703784 

Shift: Monday-Friday, Day shift

FLSA: Exempt 

Hybrid? N 

CPF Level: P5

Location: San Antonio 

Dept.: Research & Development 

Business Unit: BioBridge Global

General Summary

Responsible to manage, supervise and coordinate all scientific activities of the Center for Innovations and Biodesign at BBG‐R&D. The responsibilities include applied research, early new product or service development, clinical trials/translational research, data collection, analysis, and scientific publication.

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 BBG‐R&D lab.

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.

Proficiency in the culture of mammalian cells, primary cells, flow cytometry, and cell‐based assays with

meticulous record‐keeping.

Evaluate various modalities (eg; small molecule, genetic, biochemical) that permit tuning of innate/engineered cell functional responses and/or differentiation.

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

Demonstrate broad working knowledge of platforms and technologies to evaluate innate cell function using in vitro stimulation assays, FACS, and DNA/RNA isolation for input into various molecular or next-generation sequencing NGS assays.

Actively contribute to the successful and efficient execution of robust, state‐of‐the‐art molecular biology

methods for the characterization of the primary and engineered cells (CAR T‐cell, CAR‐NK, and CAR‐M)

manufacturing process.

Design and perform in vitro biochemical and cell‐based functional assays using primary or engineered cells (e.g.

ELISA, flow cytometry, immune cell proliferation/cytotoxicity assay and immunofluorescence imaging, etc.).

Focus on the development of strategies, preclinical assays and screens that provide framework for the evaluation of various dysfunctional states.

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.

Proficiency in multiple immunoassay techniques, such as flow cytometry, MSD, ELISA, and reporter assays.

Support manufacturing in troubleshooting/investigations; including support for person in plant activities as required.

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.

Design, plan, and independently perform in‐vitro experiments and potency assays, using a variety of molecular

biology techniques. Isolation, culturing, and analyzing hematopoietic/lymphoid lineage cells.

Data analysis using FlowJo, and GraphPad.

Production and characterization of viral vectors and analytical methodology, including ELISA and SDS‐PAGE/ Western blot.

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 to

maximize 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.

Non-Essential Tasks

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

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.

Prefer a Doctoral Degree (e.g., Ph.D., or equivalent) from an accredited college or university. The preferred degree is in Immunology, cell biology, molecular biology, Biotechnology, Biology or Bioengineering.

Licenses and/or Certifications

Valid United States Driver’s License

US Passport preferred

Experience

Requires one or more years of hands-on experience with CAR-T, CAR-NK, CAR-γδT, and/or TCR-T cell therapies/immunotherapies is required, including cell culture, immune cell activation/expansion, and viral transduction for various types of immune cells.

Requires strong understanding of innate cell biology, e.g., immune cell activation, survival, proliferation, cytotoxicity, and cancer/immune cell biology in the tumor microenvironment.

Requires strong expertise in immune regulation pathways.

Requires experience with high-dimensional FACS or spectral cytometry, transcriptional or epigenetic assessment, population labeling/tracking or fate-mapping, and/or other single-cell analytics.

Requires experience with FlowJo, GraphPad and ImageJ.

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

Hands-on experience with next-generation sequencing platform is a plus.

Experience with cell culture relevant to Mesenchymal Stem Cells (MSCs), induced‐Pluripotent Stem Cells (iPSCs),

Hematopoietic Stem Cells (HSCs), Neural Stem Cells (NSCs), Cancer Stem Cells, PBMCs, Cord blood, and Exosomes

is a plus.

Working knowledge of T cell, NK-cells, CAR-M metabolism and/or assays is a plus.

Multivariate or machine learning data analytics experience a plus (eg; JMP, python, R).

Strongly prefer applied research and product development experience.

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.

Expertise in closed‐system process development is a plus.

Hands‐on experience with gene editing techniques (transfection, transduction, and lipofection) is a plus.

Knowledge

Must have a specific understanding of the following subject matter areas: cell‐based therapeutics and applied regenerative medicine.

Must have a working knowledge of tissue and cell culture.

Must have a working knowledge of molecular biology techniques.

Must have a working knowledge of Laboratory Sciences.

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

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 maintain competency in laboratory skills for liquid and material handling.

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 a self-starter and self-directed worker.

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

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.