Senior Biologics Process Transfer Lead

Jobtailor; Redmond (WA); On-site; USD 180,000 - 230,000; Full time

Job summary

Jobtailor seeks an experienced engineer to lead late-stage molecule process transfer and technology transfer for clinical and commercial biologics manufacturing. You will develop and maintain technical documentation for process control and validation, and support global standardization across the manufacturing network.

The role requires extensive expertise in downstream processing, viral filtration, and filtration technologies, with strong GMP knowledge, and a track record mentoring engineers.

Qualifications

• Requires 12+ years engineering experience, or 8+ years with an MS.
• Experience in downstream processing including chromatography, viral filtration, and tangential flow filtration.
• Experience leading technology transfer and PPQ campaigns for late-stage clinical and commercial programs.
• Strong GMP understanding and quality systems knowledge.
• Ability to mentor junior engineers and lead cross-site teams.

Responsibilities

• Provide project leadership for late-stage molecule process transfer and technology transfer across clinical and commercial biologics manufacturing.
• Support development and maintenance of documentation for process control and validation strategies.
• Lead creation of global templates and documentation for transfer and new product introduction.
• Provide onsite support for facility startups and performance qualification runs.
• Lead development and implementation of templates for process validations and continued process verification.

Skills

Downstream Processing

Technology Transfer Leadership

Regulatory CMC Writing

Process Validation

GMP Knowledge

Statistical Analysis

Mentoring

Problem-Solving

Education

Bachelor’s degree in Engineering

MS in Engineering

Tools

DeltaV Automation Systems

Manufacturing Execution Systems

Process Data Analysis Tools

Job description

Jobtailor seeks an experienced engineer to lead late-stage molecule process transfer and technology transfer for clinical and commercial biologics manufacturing. You will develop and maintain technical documentation for process control and validation, and support global standardization across the manufacturing network.

The role requires extensive expertise in downstream processing, viral filtration, and filtration technologies, with strong GMP knowledge, and a track record mentoring engineers.