Bench Scientist

Integrated Resources Inc.; South San Francisco (CA); On-site; USD 80,000 - 130,000; Full time

Job summary

A premier staffing firm seeks a results-oriented professional to join a team focused on developing CART therapies. The role involves creating robust manufacturing processes and collaborating with various stakeholders to advance biotech solutions. Candidates should have a strong background in molecular biology or bioengineering and relevant industry experience.

Qualifications

• 3+ years experience in biotech/biopharma industry.
• 1+ years for MS degree.
• Experience in manufacturing processes for cell or gene therapies is preferred.

Responsibilities

• Contribute to development and characterization of CART manufacturing processes.
• Support clinical-scale GMP operations and successful tech transfer.
• Ensure high-quality documentation and compliance with regulatory standards.

Skills

Process development for GMP manufacturing

Cell culture and characterization of primary T-cells

Aseptic cell culture technique

T-cell activation and viral transduction

Familiarity with cGMP

Experience with process scale-up

Education

BS or MS degree in Molecular Immunology/Biology or related

Tools

WAVE bioreactors

CliniMACS Prodigy

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Duration: 18+ Months

Job Description:

Summary: We are seeking a highly motivated, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies. The successful candidate will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO. This position will also contribute to the development of Client technologies and approaches to meet future CART manufacturing needs and will work in close collaboration with key stakeholders including the CART Research and Bioprocess R&D groups.

Job Responsibilities:

• Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
• Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material.
• Contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems and automation), aligned with emerging business drivers and Regulatory expectations.
• Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups
• Demonstrate strong “personal leadership”/ accountability and technical and interpersonal skills, and apply scientific and technical experience to ensure safe, high-quality lab practices
• Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
• Present data/ strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.

Qualifications

Technical Skills Requirements:

BS or MS degree in Molecular Immunology/ Molecular Biology, Bioengineering, or related degree (with appropriate cell and gene therapy focus) with 3+ years (1+ for MS) of experience in biotech/biopharma industry (preferably in the development and characterization of manufacturing processes for cell- or gene-based therapies).

• Process development for GMP manufacturing of cell- or gene-therapies
• Culture and characterization of primary T-cells, T-cell molecular biology/ engineering
• Aseptic cell culture technique
• Direct experience with T-cell activation, viral transduction, and mRNA electroporation is highly desirable
• Familiarity with cGMP and relevant Regulatory Guidance documents a plus
• Familiarity with single-use bioprocessing such as WAVE bioreactors and CliniMACS Prodigy a plus
• Experience with process scale-up and scale-down is desired

Additional Information

Kind Regards,

Clinical Recruiter

Integrated Resources, Inc.

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