Staff Process Engineer

About the Company

Syner-G enables people to build careers that positively impact their quality of life. We accelerate breakthrough science and deliver life-enhancing therapies to patients by supporting organizations from drug discovery through commercialization. Our work is meaningful, varied, and thought-provoking, with a strategic emphasis and solutions-driven approach. Underpinning this mission is a culture that supports growth, learning, and rewards contributions in diverse ways.

Syner-G was recently honored with BioSpace's "Best Places to Work" 2026 award for the third consecutive year, reflecting our commitment to a positive and engaging work environment with a focus on culture, career growth, financial rewards, leadership, and innovation. Our team members are our most valuable asset, and we invite you to join us in shaping the future where your talents are valued and your contributions make a meaningful impact.

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. This role provides technical and program leadership for a portfolio of monoclonal antibody (mAb) drug substance technology transfers. You will manage 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 to improve execution visibility and accountability. You will leverage deep expertise in mammalian cell culture, downstream purification, process validation, and commercial manufacturing to support transfer strategies, validation planning, process risk assessments, and commercialization activities.

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.

Requirements

• BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or a related technical discipline.
• 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.

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.

Essential Functions

Physical Demands: While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment: The work environment is an indoor office setting with moderate noise levels, temperate climate, and bright lighting conducive to minimal eye strain.

Benefits

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of these pillars. This includes:

• A market-competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program, company-paid holidays, and flexible working hours.
• Fully remote work options for most positions and the ability to work "almost anywhere."
• Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India for those preferring a physical workspace.
• Ongoing recognition and career development opportunities.

Pay

The expected salary range for this position is $170,000 to $200,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa.