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Staff Process Engineer

2 months ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Syner-G BioPharma

Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services
51-250
Founded 2007
View All Jobs 10

Description

  • Lead approximately 10 concurrent monoclonal antibody drug substance technology transfer programs, managing timelines, milestones, deliverables, risks, and dependencies.
  • Drive technology transfer activities from process handoff through GMP manufacturing, PPQ execution, and commercial readiness.
  • Develop governance structures, portfolio reporting metrics, resource planning tools, and escalation pathways to improve transfer execution visibility.
  • Provide technical leadership in monoclonal antibody manufacturing, including mammalian cell culture, chromatography, filtration, UF/DF, and drug substance production.
  • Support transfer strategy development, technical readiness assessments, process fit-gap evaluations, and commercialization planning.
  • Develop and implement risk-based process validation and PPQ strategies using process characterization data, prior knowledge, and product quality requirements.
  • Evaluate process risks and critical process parameters, and ensure appropriate control strategies and Critical Quality Attribute confirmation.
  • Collaborate with MSAT, Process Development, Manufacturing, Quality, QA, Supply Chain, Regulatory Affairs, and Project Management teams.
  • Provide hands-on technical support, troubleshooting, and process assessment when required.
  • Lead commissioning, qualification, startup, and operational readiness activities related to technology transfer and process implementation.
  • Develop scalable technology transfer procedures, templates, tools, and best practices for commercial and late-stage programs.
  • Identify and mitigate technical, operational, scheduling, and resource risks while advancing programs toward 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 preferred.
  • 10–15+ years of experience in MSAT, process engineering, process development, technology transfer, or biologics manufacturing in biotechnology or pharmaceutical organizations.
  • Experience managing multiple concurrent technology transfer programs for biologic products, preferably monoclonal antibodies.
  • Extensive expertise in upstream and downstream biologics manufacturing, 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.
  • Deep understanding of monoclonal antibody 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.
  • Cannot sponsor or take over sponsorship of an employment visa at this time.

Benefits

  • Market-competitive base salary with annual incentive plan.
  • Expected salary range of $170,000 to $200,000 per year.
  • Robust benefit offerings.
  • Ongoing recognition and career development opportunities.
  • Generous flexible paid time off program.
  • Company-paid holidays.
  • Flexible working hours.
  • Fully remote work options for most positions, with the ability to work from almost anywhere.
  • Office locations available in Greater Boston, San Diego, Boulder, and India for those who prefer an on-site location.

Interested in this position?

Apply directly on the company website

Apply Now

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