Scientist I, Technology Transfer (MSAT) - Gene Therapy

job summary: An elite Contract Development and Manufacturing Organization (CDMO) specializing in advanced therapeutics is seeking a discerning Scientist I, Technology Transfer to join the Manufacturing Science and Technology (MSAT) division in Carlsbad, CA. This critical, hybrid role serves as the technical bridge translating novel viral vector processes from Process Development into full-scale cGMP Manufacturing. The successful candidate will directly impact the acceleration of next-generation gene therapy and oncology pipelines, ensuring rigorous process scale-up, robust risk mitigation, and flawless clinical manufacturing execution.

location:

Carlsbad, California job type: Contract salary: $60 - 65 per hour work hours: 9 to 5 education: Bachelors responsibilities:

Process Translation & Scale-Up:

Lead the cross-functional technical transfer of complex client processes from bench-scale development to cGMP manufacturing suites, ensuring strict adherence to project timelines and therapeutic milestones.

Technical Documentation:

Author and review critical operational documentation, including Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Bills of Materials (BOMs), and item specifications, translating complex scientific parameters into executable manufacturing instructions.

On-Floor Technical Execution:

Support cleanroom and pilot laboratory operations during engineering and full-scale pilot runs, providing expert technical oversight for viral production and purification processes while training manufacturing personnel.

Regulatory Compliance & Audit Support:

Apply deep knowledge of FDA and EMA regulatory frameworks to process designs and documentation, serving as a technical subject matter expert during client and regulatory agency site audits.

Process Intensification & Deviations:

Proactively identify process gaps, technical vulnerabilities, or operational inefficiencies; execute rigorous root-cause analyses and implement data-driven solutions to de-risk manufacturing campaigns.

Cross-Functional Material Readiness:

Coordinate internal and external material sourcing for pilot runs, defining strict material and labor requirements to optimize operational readiness.

qualifications:

Required:

Education:

Bachelor's or Master's degree in Biochemistry, Chemical Engineering, Microbiology, or a related Life Sciences discipline.

Experience:

A minimum of 7+ years (with a BS) or 5+ years (with an MS) of dedicated experience within an MSAT, process development, or cGMP biomanufacturing environment.

Technical Expertise:

Proven hands-on proficiency in either upstream cell culture unit operations (bioreactors, flask expansion, cell stacks, clarification) OR downstream purification modalities (Tangential Flow Filtration (TFF), automated chromatography skids such as ÄKTA/XMO, and sterile filtration).

Compliance:

Comprehensive understanding of Quality Systems and regulatory expectations within a validated cGMP manufacturing environment.

Preferred:

Dual-Modality Proficiency:

Direct technical competency encompassing both upstream bioprocessing and downstream purification unit operations.

CDMO Domain Expertise:

Prior experience navigating the rapid timelines and client-facing dynamics of a contract manufacturing organization.

Technical Leadership:

Demonstrated ability to influence cross-functional matrix teams, resolve complex technical issues independently, and author high-caliber technical reports for diverse scientific audiences. #LI-AO1 skills: Biology, Chromatography, Protein Purification, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Bioreactor Operation, Tangential Flow Filtration (TFF)

Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. job detailssummary$60 - $65 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53667job details job summary: An elite Contract Development and Manufacturing Organization (CDMO) specializing in advanced therapeutics is seeking a discerning Scientist I, Technology Transfer to join the Manufacturing Science and Technology (MSAT) division in Carlsbad, CA. This critical, hybrid role serves as the technical bridge translating novel viral vector processes from Process Development into full-scale cGMP Manufacturing. The successful candidate will directly impact the acceleration of next-generation gene therapy and oncology pipelines, ensuring rigorous process scale-up, robust risk mitigation, and flawless clinical manufacturing execution.

location:

Carlsbad, California job type: Contract salary: $60 - 65 per hour work hours: 9 to 5 education: Bachelors responsibilities:

Process Translation & Scale-Up:

Lead the cross-functional technical transfer of complex client processes from bench-scale development to cGMP manufacturing suites, ensuring strict adherence to project timelines and therapeutic milestones.

Technical Documentation:

Author and review critical operational documentation, including Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Bills of Materials (BOMs), and item specifications, translating complex scientific parameters into executable manufacturing instructions.

On-Floor Technical Execution:

Support cleanroom and pilot laboratory operations during engineering and full-scale pilot runs, providing expert technical oversight for viral production and purification processes while training manufacturing personnel.

Regulatory Compliance & Audit Support:

Apply deep knowledge of FDA and EMA regulatory frameworks to process designs and documentation, serving as a technical subject matter expert during client and regulatory agency site audits.

Process Intensification & Deviations:

Proactively identify process gaps, technical vulnerabilities, or operational inefficiencies; execute rigorous root-cause analyses and implement data-driven solutions to de-risk manufacturing campaigns.

Cross-Functional Material Readiness:

Coordinate internal and external material sourcing for pilot runs, defining strict material and labor requirements to optimize operational readiness.

qualifications:

Required:

Education:

Bachelor's or Master's degree in Biochemistry, Chemical Engineering, Microbiology, or a related Life Sciences discipline.

Experience:

A minimum of 7+ years (with a BS) or 5+ years (with an MS) of dedicated experience within an MSAT, process development, or cGMP biomanufacturing environment.

Technical Expertise:

Proven hands-on proficiency in either upstream cell culture unit operations (bioreactors, flask expansion, cell stacks, clarification) OR downstream purification modalities (Tangential Flow Filtration (TFF), automated chromatography skids such as ÄKTA/XMO, and sterile filtration).

Compliance:

Comprehensive understanding of Quality Systems and regulatory expectations within a validated cGMP manufacturing environment.

Preferred:

Dual-Modality Proficiency:

Direct technical competency encompassing both upstream bioprocessing and downstream purification unit operations.

CDMO Domain Expertise:

Prior experience navigating the rapid timelines and client-facing dynamics of a contract manufacturing organization.

Technical Leadership:

Demonstrated ability to influence cross-functional matrix teams, resolve complex technical issues independently, and author high-caliber technical reports for diverse scientific audiences. #LI-AO1 skills: Biology, Chromatography, Protein Purification, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Bioreactor Operation, Tangential Flow Filtration (TFF)

Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.