Staff Process Engineer

About the role

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.

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 milestones.
• Drive continuous improvement initiatives focused on transfer effectiveness, process robustness, manufacturing throughput, and operational excellence.
• Mentor engineers and technical staff while serving as a trusted advisor to internal stakeholders and client leadership teams.

Qualifications and Requirements

• Education: BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or a related technical discipline preferred.
• Technical Experience: 10–15+ years of experience in MSAT, process engineering, process development, technology transfer, or biologics manufacturing within biotechnology or pharmaceutical organizations.
• Extensive expertise in upstream and downstream biologics manufacturing processes, including mammalian cell culture, chromatography, viral clearance operations, filtration, and UF/DF.
• Hands-on experience supporting process development, manufacturing investigations, scale-up, process characterization, and technology transfer activities.
• Strong knowledge of GMP manufacturing, process validation, PPQ execution, lifecycle validation, and regulatory expectations for commercial biologics manufacturing.
• Prior MSAT leadership or technical program management experience supporting commercial biologics products preferred.
• Technical Skills: Deep understanding of mAb drug substance manufacturing processes and technology transfer methodologies.
• Strong knowledge of process validation, PPQ strategy development, process characterization, CPP/CQA assessment, and risk management principles.
• Experience with manufacturing scale-up, process monitoring, statistical analysis, and process performance evaluation.
• Ability to assess technical readiness, identify process risks, and develop mitigation strategies across multiple programs.
• Strong project and portfolio management capabilities, including management of schedules, resources, budgets, and competing priorities.
• Excellent communication, stakeholder management, leadership, and influencing skills.
• Ability to operate effectively in fast-paced, highly matrixed environments supporting multiple simultaneous programs.