Staff Process Engineer

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:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• 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.
• Demonstrated experience managing multiple concurrent technology transfer programs for biologic products, preferably monoclonal antibodies.
• 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.
• Proven leadership of cross-functional technical teams and complex manufacturing or commercialization programs.
• Experience developing portfolio governance, resource planning, risk management, and program reporting frameworks is highly desirable.
• 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.