Traveling Director of Quality

2 weeks ago

Boston MA, United States Third Rock Ventures Full time

Director Analytical Development

A Stealth Mode Third Rock Ventures Start Up is looking for a Analytical Development Leader to join our growing CMC team. The Director maintains a broad knowledge of established, emerging and highly innovative analytical tools and technologies. This role will utilize internal and external networks, and prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing outstanding analytical science

The Director takes a leadership role in setting strategic directions, assessing, and bringing new analytical capabilities into the organization, and ensuring that technical capabilities remain focused and current. This candidate would be responsible for developing our analytical control strategy, including method development, qualification, and release and stability testing programs and supporting process development activities. The candidate will ensure phase-appropriate assay development requirements are met, while having a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use. The candidate will also work closely with research to support analytical developability assessments for the pipeline. This is a great opportunity for the right individual to leverage their leadership and capabilities to establish the AD/QC function as we advance our clinical development portfolio.

Key Responsibilities:
Strategic Leadership: Develop and implement a comprehensive assay development strategy aligned with the company's mission and objectives. Set clear goals and milestones for the AD/QC team.
Oversee analytical method lifecycle from development through qualification both internally and at CMOs to support the clinical development programs. Assay development should be phase appropriate and Fit-for-Purpose to ensure quality and reliability of products.
Serve as the subject matter expert in the development of analytical control strategy and product characterization of the companys portfolio of recombinant therapeutic proteins (Multispecific antibodies & Fc-Fusions) including PTMs, such as glycosylation using LC-MS, peptide mapping, or other techniques.
Collaborate with research to support analytical assessments of candidate molecules prior to start of development
Stay current with the latest developments in assay technologies (including highly innovative and targeted analytics) and identify opportunities for innovation and improvement in our product portfolio.
Ensure that all assay development activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, EMA, ICH etc.
Manage budgets, resources, and external partnerships to maximize the efficiency and effectiveness of analytical activities.
Ensure data-driven product development: Generate robust datasets, and interpret and make data-driven decisions with the participation of broader team to guide product development.
Ensure the protection of intellectual property and the development of a strong patent portfolio.
Author and review relevant sections of regulatory filings, IND/IMPD, etc

Qualifications
MS/Ph.D. in a relevant field (e.g., Chemistry, Molecular Biology, Biochemistry, Biotechnology), with a minimum of 8 years of experience in managing analytical development teams.
Proven track record of successfully leading teams in the development of robust analytical assays in regulated GMP/GxP environments and working knowledge of relevant cGMP/ICH/FDA/EU regulations.
Proven track record in building and managing teams of highly skilled scientists and managers of various levels of experience.
Hands-on experience with characterization of protein therapeutics, including methods suitable for release and characterization
Experience leading and working collaboratively on cross-functional project teams.
Excellent leadership and interpersonal skills, with the ability to communicate complex scientific concepts effectively.
Strategic thinker with a passion for innovation and a commitment to staying at the forefront of scientific advancements.
Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and can-do attitude.
by Jobble
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