Senior Scientist

AL Solutions; Houston (TX); On-site; USD 90,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior MSAT Scientist to bridge late-stage process development and GMP manufacturing. This role involves leading technical support for GMP manufacturing, executing technology transfer, and ensuring compliance and robustness of processes. You will collaborate with cross-functional teams to enhance product lifecycle management, making a significant impact on clinical and commercial manufacturing operations. This is a fantastic opportunity for someone looking to advance their career in a dynamic and regulated environment, where your expertise will drive continuous improvement initiatives.

Benefits

Medical Insurance

Vision Insurance

Qualifications

• 5+ years of experience in MSAT or technical operations.
• Strong understanding of upstream or downstream bioprocessing.

Responsibilities

• Lead technical support for GMP manufacturing campaigns.
• Own and execute technology transfer from development to manufacturing.

Skills

MSAT

Process Development

GMP Environment

Problem-Solving

Technical Writing

Education

M.S. or Ph.D. in Chemical Engineering

Biochemistry

Biotechnology

Job description

Direct message the job poster from AL Solutions

Connecting Top Talent Within the U.S. CDMO Space

About the Role

We are seeking a Senior MSAT Scientist to join our team and play a key role in bridging late-stage process development and GMP manufacturing. This individual will be responsible for process scale-up, technology transfer, and continuous process support of clinical and commercial manufacturing operations.

You will work cross-functionally with Process Development, Manufacturing, QA, Engineering, and Regulatory teams to ensure that processes are robust, compliant, and commercially viable. This is an exciting opportunity to have a direct impact on product lifecycle management, from tech transfer through commercial validation.

Key Responsibilities

• Lead technical support for GMP manufacturing campaigns (clinical and commercial).
• Own and execute technology transfer from development or external partners into manufacturing.
• Identify, investigate, and troubleshoot process-related deviations and implement CAPAs.
• Support process scale-up and optimization activities, ensuring technical robustness and compliance.
• Write and review process documentation, including batch records, protocols, reports, and risk assessments.
• Collaborate with regulatory and quality teams to support regulatory filings and inspections.
• Provide subject matter expertise (SME) during audits and regulatory submissions.
• Analyze process data (CPV) to drive continuous improvement initiatives.

Qualifications

• M.S. or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field.
• 5+ years of experience in MSAT, process development, or technical operations in a GMP environment.
• Strong understanding of upstream or downstream bioprocessing (e.g., cell culture, purification, chromatography, filtration).
• Experience with tech transfer and process validation (PPQ) is highly preferred.
• Demonstrated ability to work cross-functionally in a fast-paced, regulated environment.
• Excellent problem-solving, communication, and technical writing skills.

Apply today and take the next step in your leadership career!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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