Process Engineer

Staff Process Engineer

Tustin, California, United States

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with Bio Space's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

POSITION OVERVIEW:

Syner-G is seeking a highly experienced Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years of biologics manufacturing experience to provide technical and program leadership for a portfolio of monoclonal antibody (mAb) drug substance technology transfers. This role will be responsible for managing approximately 10 concurrent technology transfer programs, driving cross-functional execution from process transfer through GMP manufacturing and PPQ, while ensuring technical readiness, risk mitigation, and milestone achievement.

The successful candidate will serve as a strategic partner to MSAT leadership, establishing governance, portfolio reporting, resource planning, and escalation processes that improve execution visibility and accountability. Leveraging deep expertise in mammalian cell culture, downstream purification, process validation, and commercial manufacturing, the Staff Process Engineer will support transfer strategies, validation planning, process risk assessments, and commercialization activities. The ideal candidate will combine strong program leadership capabilities with hands-on process development and manufacturing science experience to support technical troubleshooting and execution as needed.

KEY RESPONSIBILITIES:

• Lead a portfolio of approximately 10 concurrent mAb drug substance technology transfer programs, managing timelines, milestones, deliverables, risks, and cross-functional dependencies.
• Drive technology transfer activities from process handoff through GMP manufacturing, PPQ execution, and commercial readiness.
• Serve as a strategic partner to MSAT leadership by developing governance structures, portfolio reporting metrics, resource planning tools, and escalation pathways to improve transfer execution and visibility.
• Provide technical leadership and subject matter expertise in monoclonal antibody manufacturing, including mammalian cell culture, chromatography, filtration, UF/DF, and drug substance production.
• Support technology transfer strategy development, technical readiness assessments, process fit-gap evaluations, and commercialization planning.
• Develop and implement risk-based process validation and PPQ strategies utilizing process characterization data, prior process knowledge, and product quality requirements.
• Evaluate process risks and critical process parameters (CPPs), ensuring appropriate control strategies and confirmation of Critical Quality Attributes (CQAs).
• Collaborate closely with MSAT, Process Development, Manufacturing, Quality, QA, Supply Chain, Regulatory Affairs, and Project Management teams to ensure transfer readiness and successful execution.
• Provide hands-on technical support, troubleshooting, and process assessment activities when required, leveraging previous laboratory, process development, or manufacturing experience.
• Lead commissioning, qualification, startup, and operational readiness activities associated with technology transfer and process implementation.
• Develop and maintain scalable technology transfer procedures, templates, tools, and best practices to support a growing portfolio of commercial and late-stage programs.
• Identify and mitigate technical, operational, scheduling, and resource risks while advancing programs toward key…