Syner-G

Syner-G

Staff Process Engineer

Tustin, California, United States · Staff+

No sponsorship$10k-$15kDetected 7 days ago
C++StatisticsProject ManagementStakeholder ManagementSupply ChainCustomer SupportGMPFDA RegulatoryCell CultureLeadershipCommunicationRegulatory Affairs

About the role

  • 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.
  • 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.
  • 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.

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.
  • 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.
  • Collaborate closely with MSAT, Process Development, Manufacturing, Quality, QA, Supply Chain, Regulatory Affairs, and Project Management teams to ensure transfer readiness and successful execution.
  • 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.
  • Drive continuous improvement initiatives focused on transfer effectiveness, process robustness, manufacturing throughput, and operational excellence.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

  • 10-15+ years of experience in MSAT, process engineering, process development, technology transfer, or biologics manufacturing within biotechnology or pharmaceutical organizations.
  • 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.
  • Strong knowledge of process validation, PPQ strategy development, process characterization, CPP/CQA assessment, and risk management principles.
  • Provide hands-on technical support, troubleshooting, and process assessment activities when required, leveraging previous laboratory, process development, or manufacturing experience.
  • 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.

Nice to have

  • BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or a related technical discipline preferred.
  • 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.
  • Experience with manufacturing scale-up, process monitoring, statistical analysis, and process performance evaluation.
  • 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.
  • 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
  • Work Environment:
  • A career here is life-enhancing.
  • Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
  • For more information, visit www.Synergbiopharma.com

Compensation

  • 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.
  • This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
  • The expected salary range for this position is $170,000 to $200,000 yearly.

Benefits

  • This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
  • Specific vision abilities required by this position include close vision and the ability to adjust focus.

Company info

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

Visa & Work Authorization

  • Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Syner-G's careers page and normalized into a canonical job model.