What are the responsibilities and job description for the Scientist I, Manufacturing and Technology position at BioBridge Global?
BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.
Notice of Labor Condition Application Filing
This serves as notice pursuant to 20 C.F.R.
Classification Sought: H-1B Nonimmigrant
Number of Workers: 1
Job Title: Scientist I - Manufacturing and Technology
Occupational Classification: 17-2031.00 Bioengineers and Biomedical Engineers
Wage Range Offered: $86,320 to $110,073.60 per year for full-time employment
Dates of Intended Employment: 09/30/2025 to 9/29/2028
Work Locations: 6211 IH 10 West, San Antonio, Texas 78201
1305 E Houston St., San Antonio, TX 78205
The Labor Condition Application is available for public inspection at BBGAT’s principal place of business: 6211 IH 10 West, San Antonio, Texas 78201.
Job Title: Scientist I, Manufacturing and Technology
Revision: 0000
Job Code: 704200
Shift: Day Shift
FLSA: Exempt
Hybrid? N
Dept.: BBG Advanced Therapies Manufacturing
Business Unit: BBG Advanced Therapies
CPF Level: P3
General Summary
Responsible for successfully transferring processes into GMP‐compliant Production from Process Development to Commercial Manufacturing including creation and/or revision of technical documentation and execution of defined processes. These may include analytical methods, technology transfers and cGMP manufacturing. This position requires strict attention to detail, high quality customer service skills and the ability to work collaboratively within a project 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
Develop, draft, revise training documents, validation/verification plans, test cases, validation/verification summaries and review completed validations.
Collaborates with operational unit SMEs in developing and drafting production documents, e.g. policy, standard operating procedures (SOPs) work instructions, forms, job aids, Master Batch Records, material product specifications.
Ensure on‐time delivery/readiness of technology transfer (TT) campaigns, collaborating with cross‐functional teams and clients.
Develop strategies to ensure all production‐readiness requirements are met. Communicate with stakeholders to ensure all biomanufacturing requirements are met.
Lead, manage and oversee designated activities for cGMP‐compliant analytical testing and cGMP/Clinical‐scale Manufacturing including aseptic processing/manufacturing in the cleanrooms as needed.
Provide technical expertise and problem‐solving support. Identify areas of improvement and develop solutions.
Ensure compliance with all change control procedures, regulatory standards and industry best practices.
Collaborates with Quality Assurance SMEs to produce and maintain documents supporting the Quality Systems as they pertain to GenCure Process Development and Manufacturing, e.g. Quality investigation Reports/ CAPAs, Validations, Risk Assessments/FMEAs.
Develop, draft, revise scientific communications such as abstracts, case studies, book chapters, white papers and journal articles to advance GenCure Biomanufacturing capabilities.
Submit scientific communications to local and national conferences for poster and podium presentations. Demonstrate:
Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment. The required major is in a Scientific or Engineering discipline.
Licenses and/or Certifications
Valid United States Driver’s License
Experience
If Bachelor’s Degree is attained, three or more years of experience in regenerative medicine or biomanufacturing exclusive of academic experience.
If Master’s Degree is attained, requires two or more years of experience in all aspects of human cell culture and/or analytical testing relevant to regenerative medicine or biomanufacturing.
If Ph.D. is attained, requires some experience in all aspects of human cell culture and/or analytical testing relevant to regenerative medicine or biomanufacturing. Experience may be inclusive of academic training.
Prefer experience in cGMP principles, Quality Management Systems and cGMP analytical testing.
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge
Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.
Must have a working knowledge of tissue and cell culture.
Must have a specific understanding of the following subject matter areas is strongly preferred: cell biology analytical development, human cell culture, process engineering.
Skills
Must be capable of operating motor vehicles in all types of weather conditions.
Must have strong computer skills.
Must maintain competency in laboratory skills for liquid and material handling.
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 have excellent written and oral communication skills.
Must have basic library and literature‐based research skills.
Must demonstrate the ability to solve technical and/or clinical problems with biotechnology‐based solutions required.
Abilities
Must be a self‐starter and self‐directed worker.
Must be able to conduct experiments and correctly interpret test results.
Must be able to develop operational schedules of various activities; including raw materials procurement, tech transfer activities, process development activities, manufacturing events, and product testing.
Must be able to keep information confidential.
Must be able to meet deadlines, and perform accurate laboratory testing.
Must be able to train and supervise junior staff.
Must be able to work independently as well as in a team environment.
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 a team‐oriented leadership style.
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.
Occupational Exposure Assignment ‐ Category I
Physical Requirements
Requires manual and finger dexterity and eye‐hand coordination.
Will require walking, bending, and prolonged sitting and/or standing during work hours. 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:
Notice of Labor Condition Application Filing
This serves as notice pursuant to 20 C.F.R.
- 655.734that a Labor Condition Application (LCA), Form ETA-9035E, is being filed with the U.S. Department of Labor for the following:
Classification Sought: H-1B Nonimmigrant
Number of Workers: 1
Job Title: Scientist I - Manufacturing and Technology
Occupational Classification: 17-2031.00 Bioengineers and Biomedical Engineers
Wage Range Offered: $86,320 to $110,073.60 per year for full-time employment
Dates of Intended Employment: 09/30/2025 to 9/29/2028
Work Locations: 6211 IH 10 West, San Antonio, Texas 78201
1305 E Houston St., San Antonio, TX 78205
The Labor Condition Application is available for public inspection at BBGAT’s principal place of business: 6211 IH 10 West, San Antonio, Texas 78201.
Job Title: Scientist I, Manufacturing and Technology
Revision: 0000
Job Code: 704200
Shift: Day Shift
FLSA: Exempt
Hybrid? N
Dept.: BBG Advanced Therapies Manufacturing
Business Unit: BBG Advanced Therapies
CPF Level: P3
General Summary
Responsible for successfully transferring processes into GMP‐compliant Production from Process Development to Commercial Manufacturing including creation and/or revision of technical documentation and execution of defined processes. These may include analytical methods, technology transfers and cGMP manufacturing. This position requires strict attention to detail, high quality customer service skills and the ability to work collaboratively within a project 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
Develop, draft, revise training documents, validation/verification plans, test cases, validation/verification summaries and review completed validations.
Collaborates with operational unit SMEs in developing and drafting production documents, e.g. policy, standard operating procedures (SOPs) work instructions, forms, job aids, Master Batch Records, material product specifications.
Ensure on‐time delivery/readiness of technology transfer (TT) campaigns, collaborating with cross‐functional teams and clients.
Develop strategies to ensure all production‐readiness requirements are met. Communicate with stakeholders to ensure all biomanufacturing requirements are met.
Lead, manage and oversee designated activities for cGMP‐compliant analytical testing and cGMP/Clinical‐scale Manufacturing including aseptic processing/manufacturing in the cleanrooms as needed.
Provide technical expertise and problem‐solving support. Identify areas of improvement and develop solutions.
Ensure compliance with all change control procedures, regulatory standards and industry best practices.
Collaborates with Quality Assurance SMEs to produce and maintain documents supporting the Quality Systems as they pertain to GenCure Process Development and Manufacturing, e.g. Quality investigation Reports/ CAPAs, Validations, Risk Assessments/FMEAs.
Develop, draft, revise scientific communications such as abstracts, case studies, book chapters, white papers and journal articles to advance GenCure Biomanufacturing capabilities.
Submit scientific communications to local and national conferences for poster and podium presentations. Demonstrate:
- Respect for co‐workers and management staff
- Excellent customer service [for both internal and external customers]
- Adherence to all safety, regulatory, and quality requirements
- Continuous improvement Performs other duties as assigned.
Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment. The required major is in a Scientific or Engineering discipline.
Licenses and/or Certifications
Valid United States Driver’s License
Experience
If Bachelor’s Degree is attained, three or more years of experience in regenerative medicine or biomanufacturing exclusive of academic experience.
If Master’s Degree is attained, requires two or more years of experience in all aspects of human cell culture and/or analytical testing relevant to regenerative medicine or biomanufacturing.
If Ph.D. is attained, requires some experience in all aspects of human cell culture and/or analytical testing relevant to regenerative medicine or biomanufacturing. Experience may be inclusive of academic training.
Prefer experience in cGMP principles, Quality Management Systems and cGMP analytical testing.
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge
Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.
Must have a working knowledge of tissue and cell culture.
Must have a specific understanding of the following subject matter areas is strongly preferred: cell biology analytical development, human cell culture, process engineering.
Skills
Must be capable of operating motor vehicles in all types of weather conditions.
Must have strong computer skills.
Must maintain competency in laboratory skills for liquid and material handling.
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 have excellent written and oral communication skills.
Must have basic library and literature‐based research skills.
Must demonstrate the ability to solve technical and/or clinical problems with biotechnology‐based solutions required.
Abilities
Must be a self‐starter and self‐directed worker.
Must be able to conduct experiments and correctly interpret test results.
Must be able to develop operational schedules of various activities; including raw materials procurement, tech transfer activities, process development activities, manufacturing events, and product testing.
Must be able to keep information confidential.
Must be able to meet deadlines, and perform accurate laboratory testing.
Must be able to train and supervise junior staff.
Must be able to work independently as well as in a team environment.
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 a team‐oriented leadership style.
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.
Occupational Exposure Assignment ‐ Category I
Physical Requirements
Requires manual and finger dexterity and eye‐hand coordination.
Will require walking, bending, and prolonged sitting and/or standing during work hours. 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
- Incentive Compensation Plan
- Group Health Medical Plan with prescription coverage
- Shift Differentials
- Variety of Voluntary Supplemental Insurances
- Paid Holidays
- Voluntary Dental Coverage
- Educational Assistance Program
- Voluntary Vision
Salary : $86,320 - $110,074
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