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VP, CMC - Small Molecule

Employer
Mirador Therapeutics, Inc.
Location
San Diego, CA
Start date
Apr 14, 2024

View more

Discipline
Science/R&D, CMC
Required Education
Masters Degree/MBA
Position Type
Contract
Hotbed
Biotech Beach

Job Details

(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 highly motivated individual to head up the CMC function. The candidate will be responsible for phase appropriate CMC development and manufacturing strategies, due diligence, identifying and implementing necessary process improvements, oversight of activities at contract development and manufacturing organizations (CDMOs), and authoring and review of relevant submissions to regulatory agencies.

Responsibilities

  • Responsible for technical leadership and operational management of formulation, drug product and supply chain activities.
  • Establish and oversee activities, including process optimization, solid-state and formulation development, API and drug product manufacturing at external laboratories and manufacturing facilities.
  • Development and implementation of phase appropriate CMC development and manufacturing strategies from early clinical to commercial stages.
  • Identification of necessary process improvements, and management of development/ implementation of process improvements at external manufacturing sites.
  • Oversight of proper execution of manufacturing runs at external CDMOs, ensuring supply for on-going and planned non-clinical studies and clinical trials.
  • In coordination with internal partners including Clinical Operations, Project Management and external CDMOs, forecasting of manufacturing needs and scheduling of manufacturing runs in accordance with program timelines and budgets.
  • Interaction as process development and manufacturing leader with internal and external parties, including Program Management, Analytics, Regulatory Affairs, and Quality Assurance.
  • Identification and communication of risks in the manufacturing process and their mitigation.
  • Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed. Contribute to building and maintaining phase-appropriate Quality infrastructure in support of external CMC operations.
  • Act as process and technical expert during regulatory interactions.
  • Representation of the company as overall manufacturing process expert during diligence and partner company interactions.

Qualifications

  • Master’s degree or PhD in Chemistry or related discipline.
  • 10 or more years of experience in manufacturing and CMC activities within the Biotechnology or Pharmaceutical industry, with significant experience in the field of small molecule drug development.
  • Technical depth and a broad understanding of chemical process, analytical and formulation development.
  • Expertise overseeing the design of new syntheses and process improvements to achieve bulk and quality goals, to ensure that API processes and manufacture of Drug Substance can be successfully accomplished.
  • Demonstrated proficiency in small molecule reformulation/formulation development is desirable.
  • Proficient in the management of Contract Manufacturing Organizations, leading GMP manufacturing activities, and managing drug supply for clinical studies.
  • Operational experience and familiarity with the drug development process, including external regulatory requirements and cGMP.
  • Experience in authoring and reviewing CMC sections of regulatory dossiers, and interactions with global regulatory agencies.
  • Ability to provide input on and set overall CMC strategy.
  • Expertise in early development as well as late stage/commercial small molecules, preferably in direct management of multiple disciplines and platforms.
  • People management experience.

Skills and Abilities

  • Excellent communication and collaboration skills across levels and functions.
  • Ability to work independently and collaboratively in a highly dynamic work environment
  • Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
  • Ability to set priorities, work independently and deliver results in a timely manner.
  • Sound strategic, technical, operational, and ethical judgment with uncompromising integrity.

The expected base pay range for this position is $250,000 – $375,000 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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Company

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. For more information, please visit us at www.miradortx.com and follow us on LinkedIn.

Company info
Website
Location
3115 Merryfield Row, Suite 210
San Diego
California
92121
United States

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