Senior Manager, CMC – Manufacturing and R&D - San Diego, CA
Company: Mirador Therapeutics, Inc.
Location: San Diego
Posted on: March 5, 2026
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Job Description:
Mirador Therapeutics, Inc. is a clinical-stage precision
medicine company focused on developing first-and/or best-in-class
next-generation therapeutics for immunology and inflammation. The
company’s Mirador360™ precision development engine leverages the
latest advances in human genetics and data science to rapidly
deliver new precision medicines for patients living with
immune-mediated inflammatory and fibrotic diseases. Mirador has
raised over $650 million from leading life sciences investors and
is based in San Diego, CA. Mirador was named Best Places to Work by
Biospace and is a Great Place to Work-Certified™ Company. 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 $140,000 - $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. LI-onsite Working at Mirador Therapeutics | Great Place To
Work® All qualified applicants are considered for employment
without regard to race, color, religion, age, sex, sexual
orientation, gender identity, national origin, disability, veteran
status or other protected class. Read our Job Applicant Privacy
Policy
Keywords: Mirador Therapeutics, Inc., Pasadena , Senior Manager, CMC – Manufacturing and R&D - San Diego, CA, Science, Research & Development , San Diego, California
