(San Diego, CA)
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
We are seeking a strategic and technical leader to build and lead both the biologics and small molecule analytical development and QC function in support of our innovative, fast-growing pipeline of novel therapies. The ideal candidate will be able to apply state-of-the-art analytical method development, product characterization and quality control for biologics, including ADCs, and small molecules across the drug development phases. The ideal candidate must have demonstrated analytical & QC experience across regulatory regions in establishing accepted product control strategies from pre-clinical to commercialization.
Responsibilities
- Lead and oversee the analytical development & QC function in developing robust phase-appropriate analytical methods for characterization and release of intermediates, active pharmaceutical ingredients, and drug product candidates in the pipeline.
- Build a high performing analytical/QC function within CMC to support clinical development and commercialization of large and small molecule programs.
- Assist in the selection of CDMOs and contract laboratories for non-GMP/GMP development and manufacturing.
- Lead and oversee analytical development in designing and developing robust phase-appropriate analytical methods for characterization and routine testing of materials.
- Collaborate with cross-functional teams, including QA and Regulatory, to ensure alignment of analytical methods and controls with overall project goals.
- Execute the overall analytical development control strategy throughout development with robust analytical and biological methods for the characterization of starting materials, intermediates, products, and known/potential impurities.
- Enable product characterization capabilities across vendors to demonstrate product understanding and comparability through development life cycle.
- Guide critical quality attribute, specification, and control strategy development.
- Ensure phase appropriate method qualification and testing activities for biologic/small molecule products are available at qualified vendors.
- Manage investigational testing and assist with deviations/investigations/CAPA's as they pertain to both internal and external (CDMOs) quality management systems.
- Implement and maintain analytical testing procedures in compliance with regulatory requirements based on relevant guidance and accepted standard organizations (e.g., USP, EP, JP, etc.).
- Expertise in developing and validating both biologic and small molecule analytical methods early and late-stage products in development.
- Oversee all analytical based activities at CDMOs by providing analytical development and testing guidance to ensure all analytical methodologies are robust and in compliance.
- Develop team members, both internally and at selected partners, to continually improve their technical capabilities.
- In conjunction with other CMC members and QA, communicate product quality risks at all stages of development.
- Complete projects within established timelines, resource constraints and regulatory requirements.
- Work closely with regulatory CMC to ensure that analytical methods and specifications meet all regulatory guidelines and are properly represented in regulatory filings.
- Author/review regulatory submissions to include all relevant analytical data and documentation in support of clinical/commercial products.
Experience and Qualifications
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- 12 years or more of biotech or pharmaceutical industry experience leading analytical development and QC of both large and small molecules within a CMC department with at 6 years or more in a leadership position.
Essential Skills and Abilities
- Excellent leadership, communication, and project management skills.
- Demonstrated leadership of analytical development and QC teams both internally and externally.
- Generate and analyze data to guide critical decision making within CMC which could include the use of statistical analysis and data mining for quality trending.
- Knowledgeable on current regulatory requirements and industry practices in the analytical development and QC functions.
- Excellent verbal and written communication skills with the ability to communicate with vendors, internal teams (including management), and regulators.
- Flexible and “hands-on” to navigate between strategic and technical roles.
- Able to work in a fast-paced bio-tech environment while managing multiple projects.
- Attend teleconferences/meetings during non-core hours based on the location of vendors including the ability to travel ≥25%.
The expected base pay range for this position is $200,000 – $275,000 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.
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.
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