CMC Biologics Manufacturing & Development Lead

BioSpace; San Diego (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Bonus

Equity

Comprehensive benefits

Job summary

Mirador Therapeutics, Inc. is seeking a senior CMC leader to oversee biologics development and manufacturing for clinical supplies. You will coordinate CMOs for Cell Line/MCB, Drug Substance, Drug Product, and Device development, with emphasis on technology transfer and cGMP compliance.

The role requires directing cross-functional teams, ensuring data integrity, and enabling rapid decision-making for accelerated timelines. Travel ~25% domestically and internationally.

Qualifications

• Master’s degree in Biology, Biochemistry, Chemical Engineering or related discipline. PhD preferred.
• 8+ years of experience in biotech/pharma with biologics development/manufacturing.
• Experience managing third-party CMOs and technology transfer.
• Knowledge of cGMPs, FDA/EU/ICH guidelines and regulatory submissions.

Responsibilities

• Provide technical oversight of biologics development and manufacturing for clinical supplies.
• Review cGMP activities at CMOs and support regulatory submissions.
• Develop data management framework for development and cGMP manufacturing data.
• Drive readiness for mid-phase programs and pivotal batch manufacture.

Skills

Strong communication

Cross-functional leadership

Project management

Regulatory awareness

Strategic decision making

Time management

Education

Master’s degree in Biology or related field

PhD degree preferred

Job description

Mirador Therapeutics, Inc. is seeking a senior CMC leader to oversee biologics development and manufacturing for clinical supplies. You will coordinate CMOs for Cell Line/MCB, Drug Substance, Drug Product, and Device development, with emphasis on technology transfer and cGMP compliance.

The role requires directing cross-functional teams, ensuring data integrity, and enabling rapid decision-making for accelerated timelines. Travel ~25% domestically and internationally.