Remote Senior MSAT Process Engineer – mAb Tech Transfer

Initial Therapeutics, Inc.; Tustin (CA); On-site; USD 170,000 - 200,000; Full time

Job summary

Syner-G is seeking a Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years of biologics experience to oversee ~10 concurrent monoclonal antibody technology transfers.

You will drive handoff to GMP manufacturing, PPQ, and commercialization readiness, partnering across MSAT, Process Development, Manufacturing, Quality, Regulatory, and PM to ensure timely milestones and robust risk management.

Qualifications

• 10–15+ years MSAT/process engineering/tech transfer experience in biologics.
• Experience managing multiple concurrent technology transfer programs for biologics (mAbs preferred).
• Deep expertise in upstream and downstream biologics manufacturing including mammalian cell culture, chromatography, filtration, UF/DF.
• Strong GMP, validation, PPQ knowledge for commercial biologics manufacturing.
• Proven cross-functional leadership and program management experience.

Responsibilities

• Lead portfolio of ~10 concurrent mAb technology transfer programs with milestones and risks.
• Drive tech transfer from process handoff through GMP manufacturing and PPQ.
• Partner with MSAT leadership; develop governance, reporting metrics, and escalation paths.
• Provide SME in mAb manufacturing: cell culture, chromatography, filtration, UF/DF, drug substance production.
• Support transfer strategies, validation planning, risk assessments, and commercialization planning.
• Develop and implement risk-based validation and PPQ strategies using data and QA requirements.
• Assess CPPs and CQAs; ensure proper control strategies.
• Collaborate with MSAT, Process Development, Manufacturing, Quality, QA, Regulatory, and PM teams.
• Provide hands-on technical support for troubleshooting and transfer activities.
• Lead commissioning, qualification, startup, and operational readiness for transfers.
• Develop scalable transfer procedures, templates, and best practices for portfolio growth.
• Identify and mitigate technical, operational, scheduling, and resource risks.
• Drive continuous improvement for transfer effectiveness and throughput.
• Mentor engineers and serve as advisor to stakeholders.

Skills

MSAT leadership

cross-functional leadership

portfolio governance

process validation

risk management

project management

monoclonal antibodies

statistical analysis

Education

BS or MS in Chemical/Biochemical/Bioprocess Engineering or related

Job description

Syner-G is seeking a Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years of biologics experience to oversee ~10 concurrent monoclonal antibody technology transfers.

You will drive handoff to GMP manufacturing, PPQ, and commercialization readiness, partnering across MSAT, Process Development, Manufacturing, Quality, Regulatory, and PM to ensure timely milestones and robust risk management.