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. Syner-G was recently honored with BioSpace'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.
Staff Process Engineer
Location
United States
Posted
7 days ago
Salary
$170K - $200K / year
Seniority
Lead
Job Description
Staff Process Engineer
Syner-G
Role Description 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. Qualifications - BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or a related technical discipline preferred. - 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. Requirements - 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. Benefits - Market competitive base salary and annual incentive plan. - Robust benefit offerings. - Ongoing recognition and career development opportunities. - Generous flexible paid time off program. - Company-paid holidays. - Flexible working hours and fully remote work options for most positions. - Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India for those who prefer a physical work location. Company Description 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. Syner-G was recently honored with BioSpace'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.
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