Senior Manager, CMC – Manufacturing and R&D - San Diego, CA

Summary

This position will be responsible for technical oversight of biologics development and manufacturing to deliver clinical trial supplies across multiple clinical biologics programs.

Responsible for oversight of technical aspects of the biologics process development and manufacturing activities at contract manufacturing organizations (CMOs) including Cell Line/Master Cell Bank, Drug Substance, Drug Product, and Device development, scale-up, technical transfers, cGMP manufacturing, process characterization, validation, and delivery of launch supplies.

Daily activities include oversight of cGMP activities occurring at CMOs, providing technical input to development activities and objectives, leveraging data generated by external service providers to enable strategic decision-making.

Responsibilities

• Supports the CMC team in authoring Quality sections for global regulatory filings, answering regulatory inquiries and providing assessments for change management and/or deviation investigations.
• Reviews and provides active technical feedback to process development objectives, study design, and outcomes/data to drive scientifically rigorous development work at external CMO partners and achieves optimal development outcomes on accelerated timelines.
• Reviews and provides feedback to all documentation related to the cGMP production of biologics products including but not limited to process descriptions, master batch records, executed batch records, sampling plans, protocols, and reports. Provides technical oversight for all operational aspects of the manufacture of drug substance or drug product at CMOs.
• Implements and maintains a data management framework for standardization and internalization of development and cGMP manufacturing data for all of Mirador’s biologics programs.
• Identifies and executes deliverables to achieve readiness of mid-phase programs for pivotal batch manufacture, and for commercial launch.
• Navigates prioritization and completion of deliverables on critical DNA to IND timeline to achieve early-phase program objectives on accelerated timelines.

Experience and Qualifications

• Master’s degree in Biology, Biochemistry, Chemical Engineering or related discipline. PhD degree preferred.
• 8 years or more of experience in the biotech or pharma industry.
• Demonstrated scientific knowledge relevant to development and manufacture of biologic drug substances and/or products with understanding of phase appropriate development.
• Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations.
• Requires strong understanding of technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.

Skills and Abilities

• Self-starter who can work independently and can prioritize tasks, manages support of multiple cross-functional projects in parallel.
• Strong communication skills, (both written and oral) including presentations to internal and external audiences and experts.
• Comfortable working cross-functionally to engage with stakeholders in other teams, can lead cross-functional meetings where decisions are made, and can serve as a singular representative of Mirador’s CMC function internally and externally.
• Strong understanding and working knowledge of cGMP, ICH guidelines, CFR, Eudralex, and other regulatory authority guiding principles for biologics pharmaceutical development and operations.
• Ability to work across locations and time zones; must be able to travel approximately 25% including international travel.

The expected base pay range for this position is $125,000 - $175,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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