Downstream Process Lead for Drug Substance (GMP)

QCS Staffing; North Carolina; On-site; USD 140,000 - 190,000; Full time

Job summary

A leading biotechnology firm is seeking a Downstream Technical Package Owner in North Carolina for a 12-month contract. The role involves managing the full downstream equipment lifecycle for a new biomanufacturing plant and acting as a Subject Matter Expert in downstream processes. Ideal candidates will have a background in Chemical or Biochemical Engineering and extensive experience in drug substance biologics projects.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related discipline.
• Extensive experience in process engineering, CQV, or project management, strong focus on drug substance biologics projects.
• In-depth knowledge of downstream manufacturing processes.
• Proven experience in the design, specification, SATs, and FATs for process equipment.
• Strong technical expertise in drug substance equipment.
• Familiarity with GMP regulations, safety standards, and industry best practices.
• Excellent problem-solving, communication, and team collaboration skills.

Responsibilities

• Lead and manage the full downstream equipment lifecycle and engineering scope for greenfield drug substance manufacturing lines.
• Work closely with cross-functional teams to ensure timely and effective execution.
• Act as the technical Subject Matter Expert in downstream processes.
• Oversee the design and specifications of process equipment.
• Coordinate Factory Acceptance Tests and Site Acceptance Tests for equipment.
• Provide technical support throughout the project lifecycle.
• Review and recommend improvements to processes and procedures.
• Ensure integration of process systems aligns with quality standards.
• Support commissioning and qualification efforts for process equipment.

Job description

A leading biotechnology firm is seeking a Downstream Technical Package Owner in North Carolina for a 12-month contract. The role involves managing the full downstream equipment lifecycle for a new biomanufacturing plant and acting as a Subject Matter Expert in downstream processes. Ideal candidates will have a background in Chemical or Biochemical Engineering and extensive experience in drug substance biologics projects.