Manufacturing Supervisor

BioTalent; Tustin (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

BioTalent is seeking an experienced Supervisor, Manufacturing Downstream to lead a high-performing team in biologics production. You will oversee downstream purification operations, drive cGMP compliance, and support the production of innovative biopharmaceutical products.

The role requires 3–5+ years in downstream biopharma manufacturing with 3+ years in a supervisory capacity, strong chromatography/TFF purification expertise, and solid GMP documentation knowledge.

Qualifications

• Bachelor’s degree in Biology, Biotechnology, Chemical Engineering, or related field.
• 3–5+ years of downstream biopharmaceutical manufacturing experience.
• 3+ years of supervisory experience in downstream manufacturing.
• Strong experience with chromatography and purification processes.
• Solid knowledge of GMP documentation, deviations, and CAPAs.
• Proven leadership, communication, and problem-solving skills.

Responsibilities

• Supervise downstream manufacturing operations in a GMP environment.
• Lead chromatography, TFF/UFDF, nanofiltration, and purification activities.
• Coordinate daily production schedules and manufacturing priorities.
• Review Batch Records, SOPs, and manufacturing documentation.
• Lead deviation investigations and CAPA implementation.
• Support technology transfer and new process implementation.
• Partner with QA, QC, Validation, and Engineering teams.
• Mentor and develop manufacturing personnel while promoting operational excellence.

Skills

Leadership

GMP compliance

CAPA handling

Problem-solving

Communication

Education

Bachelor’s degree in Biology, Biotechnology, Chemical Engineering, or related field

Tools

Chromatography

TFF/UFDF

Purification

Aseptic processing

Job description

Are you an experienced Downstream Manufacturing professional ready to lead a high-performing team in biologics manufacturing?

We're seeking a Supervisor, Manufacturing Downstream to oversee purification operations, drive cGMP compliance, and support the production of innovative biopharmaceutical products.

What You’ll Do

• Supervise downstream manufacturing operations in a GMP environment.
• Lead chromatography, tangential flow filtration (TFF), nanofiltration, and purification activities.
• Coordinate daily production schedules and manufacturing priorities.
• Review Batch Records, SOPs, and manufacturing documentation.
• Lead deviation investigations and CAPA implementation.
• Support technology transfer and new process implementation.
• Partner with QA, QC, Validation, and Engineering teams.
• Mentor and develop manufacturing personnel while promoting operational excellence.

We're Looking For

• Bachelor’s degree in Biology, Biotechnology, Chemical Engineering, or related field.
• 3–5+ years of downstream biopharmaceutical manufacturing experience.
• 3+ years of supervisory experience in downstream manufacturing.
• Strong experience with chromatography, TFF/UFDF, purification, and aseptic processing.
• Excellent knowledge of GMP documentation, deviations, and CAPAs.
• Strong leadership, communication, and problem-solving skills.

Applicants must be authorized to work in the U.S. Sponsorship is not available.

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