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Director/Senior Director, Analytical CMC

Location: Cambridge
Posted on: March 15, 2023

Job Description:

Director/Senior Director, Analytical CMC at Flare Therapeutics Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare's team has uncovered 'switch sites,' druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare's drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated genetically-defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. We are a collective of brilliant fires, trailblazing a path to conquer transcription factors and create cutting-edge medicines for patients. We embrace diversity in all its forms, experiences, and viewpoints. We are inspired by the unknown and willing to take risks. We are passionate about the science we pursue and compassionate about the patients it stands to benefit. And we respect, value, and believe in each other. In this role you will...

  • Lead the CMC analytical project operations, ensuring Flare analytical CMC development activities align with phase appropriate regulatory requirements and expectations for the drug product, drug substance, and proposed regulatory starting materials processes
  • Support the CMC team's impurity control strategy through the development of appropriate methods and testing strategies
  • Lead the development, setting, and justification of phase appropriate specifications and methods to support regulatory filings through clinical development into commercial
  • Manage and oversee stability studies and reference standard qualifications
  • Ensure effective and comprehensive functional area oversight of contract research/manufacturing vendors
  • Review and support CDMO deviation investigations
  • Provide functional area data review and analysis and support technical development and troubleshooting
  • Act as subject matter expert and company representative during partner due diligence activities and regulatory inspections
  • Author and review technical reports to support regulatory submissions
  • Assist in the authoring of regulatory submissions and responses About you...
    • You have a Ph.D. in analytical chemistry
    • You have at least 15 years of experience in the biotech or pharmaceutical industry
    • You have deep knowledge in analytical GxP requirements, especially related to clinical trial development and commercial supply operations
    • You have experience managing contract research, development and manufacturing organizations
    • You have experience with support of regulatory inspections, inspection readiness activities, and compliance support during such inspections
    • You will have experience leading analytical chemistry efforts for both early phase and late phase (e.g. NDA) efforts
    • You consider yourself to be a self-starter with a great ability to prioritize and balance multiple tasks, meet multiple deadlines, and thrive in a dynamically changing and fast-paced environment
    • You have strong communication skills, both written and verbal, including strong presentation skills
    • You have a strong passion for science and are driven by making a meaningful contribution for patients Flare is proud to foster a diverse, equitable and inclusive company culture that embraces all people that are essential to who we are, what we do and what we believe. Flare Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. TO ALL AGENCIES:Please, no phone calls or emails to any employee of Flare about our openings. All resumes submitted by search firms/employment agencies to any employee at Flare via email, the internet or in any form and/or method will be deemed the sole property of Flare, unless such search firms/employment agencies were engaged by Flare for this position and a valid agreement with Flare is in place. In the event a candidate who was submitted outside of the Flare agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Director/Senior Director, Analytical CMC, Executive , Cambridge, Massachusetts

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