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Syner-G

Staff Process Engineer

RemoteUnited States only
Published
Experience
Staff
$170k–$200k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Staff-level process engineer/MSAT technology transfer lead with 10–15+ years in biologics manufacturing. Must have deep mAb drug substance, mammalian cell culture, downstream purification, GMP, PPQ/process validation, and cross-functional program leadership experience. US role; Syner-G cannot sponsor visas.

What you'll do

  • 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.

What they require

  • 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.
  • Preferred: Experience developing portfolio governance, resource planning, risk management, and program reporting frameworks is highly desirable.
  • Preferred: Prior MSAT leadership or technical program management experience supporting commercial biologics products preferred.
  • 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.
  • 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 by this position include close vision and the ability to adjust focus.
  • Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
  • Syner-G is an E-Verify employer.

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
  • Fully remote work options for most positions
  • Ability to work “almost anywhere”
  • Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India

Syner-G

Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.

Biopharma

Details

Visa sponsorshipNo
Apply routeGreenhouse
$170k–$200k/yr