Senior CMC Biologics Lead — Manufacturing & Tech Transfer

BioSpace; San Diego (CA); On-site; USD 140,000 - 175,000; Full time

Benefits offered by this job

Bonus

Equity

Comprehensive benefits

Job summary

Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on immunology and inflammation.

This role oversees biologics development and manufacturing to deliver clinical trial supplies across programs, including CMOs and cGMP activities, with emphasis on product transfer, process characterization, and data-driven decision making. The position requires a Master’s degree (PhD preferred), 8+ years in biotech/pharma, and experience with regulatory guidelines and technology

Qualifications

• Master’s degree in a related field; PhD preferred.
• 8+ years of biotech/pharma experience.
• Experience managing and influencing external CMOs globally.
• Strong knowledge of regulatory guidelines (FDA/ICH) and CMC submissions.

Responsibilities

• Oversee cGMP activities at CMOs for biologics development and manufacturing.
• Provide technical input to development objectives and data-driven decisions.
• Review documentation related to cGMP production including batch records and protocols.
• Lead data management framework for standardizing development and manufacturing data.
• Identify deliverables to readiness for mid-phase programs and commercial launch.
• Coordinate prioritization and completion of critical DNA to IND timelines.

Skills

Self-starter

Communication

Cross-functional leadership

Stakeholder engagement

Travel readiness

Education

Master’s degree in Biology/Biochemistry/Chemical Engineering

PhD preferred

Job description

Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on immunology and inflammation.

This role oversees biologics development and manufacturing to deliver clinical trial supplies across programs, including CMOs and cGMP activities, with emphasis on product transfer, process characterization, and data-driven decision making. The position requires a Master’s degree (PhD preferred), 8+ years in biotech/pharma, and experience with regulatory guidelines and technology