Maverick is pioneering the next generation of potent, selective immunotherapies for solid tumor indications. Our novel therapeutic platform, COBRA™ is the most advanced bispecific T-cell engaging platform in its class. Maverick was founded in 2016 by a team of leading experts in protein engineering, immunology and T cell therapeutic research and development. In early 2017, Maverick announced $125 million of committed funding from Takeda Pharmaceuticals, MPM BioVentures 2014 and MPM Capital’s UBS Oncology Impact Fund. Based on the promise of the Company’s early-stage research, Maverick entered a five-year drug development project with Takeda.
This position will lead and coordinate product characterization, analytical method development/qualification/validation and technology transfer to QC laboratories as well as provide oversight to external QC testing in support of Maverick’s immune oncology therapeutics. This key role will be responsible for the CMC-analytical aspects of regulatory filings and related regulatory agency interactions.
- Utilize internal and external resources, develop, characterize, transfer analytical methods and provide oversight to QC testing, enabling the manufacture, testing and release of Maverick immune oncology therapeutics.
- Provides strategic input and risk assessments and oversees preparation of CMC regulatory submissions.
- Interacts with regulatory agencies.
- Develops corporate and/or organizational policies and authorizes their implementation.
- Provides direction to team in various areas and/or groups.
- Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Direct and influence the activities of multiple functional areas, divisions, product or service groups.
- Typically requires an M.S. or Ph.D. degree in a relevant technical field and a minimum of 10 years CMC -Analytical and QC experience in development, technology transfer, and QC testing in the pharmaceutical industry. Without an advanced degree, the additional related experience is required.
Knowledge, Skills and Abilities:
- Strong Analytical Development and product characterization and background.
- Experience in cell-based bioassays for potency
- Demonstrated experience in evaluating, selecting and managing contract service providers for early-stage, and late-stage programs and commercial launch.
- Experience in early-stage drug development. Track record of successful IND, BLA, or MAA programs desired.
- Experience with pre- and post-launch activities in the biopharmaceutical industry.
- Strong working knowledge of US and EU regulations and guidelines with a good understanding of GMPs.
- Demonstrated leadership in leading technical programs.
- Strong analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions.
- Serve as the subject matter expert in drug development on CMC team.
- Expertise in developing and managing process / analytical development, including those performed at external CMOs.
- Experience in managing Phase I to launch analytical-CMC activities.
- Experience in preparation of CMC sections in regulatory filings.
- Ability to travel contract manufacturing/testing sites.