Senior MSAT & Process Development Lead

Cirsium Biosciences; Northern, San Diego (KY, CA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Generous PTO

Health Insurance

Health Savings Account

Vision Insurance

Employee Assistance Program (EAP)

Stock Options

Professional Development Opportunities

401(k) Plan

Life & AD&D Insurance

Job summary

Cirsium Biosciences is seeking a hands-on Manager/Senior Manager, Process Development, MSAT & Technology Transfer to lead upstream and downstream development, tech transfer, and manufacturing readiness. You will collaborate across Research, Process Development, Analytical Development, QA, Regulatory, and Manufacturing to translate early-stage science into scalable, validated manufacturing processes.

The role emphasizes GMP/CMC readiness, cross-functional leadership, and the ability to drive

Qualifications

• Bachelor-level or higher experience in biopharmaceutical process development or related field.
• Experience leading upstream/downstream development and technology transfer.
• Strong GMP/CMC knowledge and regulatory readiness mindset.
• Ability to translate early-stage science into controlled, scalable processes.
• Demonstrated cross-functional collaboration across R&D, QA, Regulatory, and Manufacturing.
• Hands-on leadership with troubleshooting and scale-up activities.
• Experience with technology transfer to internal or external manufacturers.

Responsibilities

• Provide hands-on technical leadership for upstream and downstream process development.
• Lead MSAT activities and bridge Research, Process Development, and Manufacturing.
• Drive scale-up, process characterization, robustness, and process understanding.
• Identify critical parameters and controls; manage technology transfer packages.
• Collaborate with Quality, Regulatory, Analytical Development, and Partners.
• Support transfer to external manufacturing and continuous improvement initiatives.

Skills

Process Development

MSAT

Technology Transfer

GMP/CMC Knowledge

Cross-functional Leadership

Troubleshooting

Scale-up

Job description

Cirsium Biosciences is seeking a hands-on Manager/Senior Manager, Process Development, MSAT & Technology Transfer to lead upstream and downstream development, tech transfer, and manufacturing readiness. You will collaborate across Research, Process Development, Analytical Development, QA, Regulatory, and Manufacturing to translate early-stage science into scalable, validated manufacturing processes.

The role emphasizes GMP/CMC readiness, cross-functional leadership, and the ability to drive