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Associate Director, Analytical Development

Company: Loves Furniture
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Position: Associate Director, Analytical Development Location: Cambridge, MA
Job Id: 210208 # of Openings: 1 Summary:-- Solid's Start: Solid is the English translation of Eytan, the Hebrew name of Solid's co-founders Ilan and Annie Ganot's son, Eytani, who was diagnosed with Duchenne muscular dystrophy (Duchenne) in 2012 at the age of 3. Unsatisfied with the existing Duchenne treatment landscape, the Ganots built a disease-focused company with the people and potential to advance innovative science quickly and responsibly. Solid's Culture:--Much of what you can learn about Solid and our culture can be found in our name. We come to work each day for the Duchenne community, and that community is our family. We have a collective strength and determination that propels us to embrace innovation and challenge the status quo because central to all that we do is the unwavering commitment to advance meaningful therapies for the Duchenne community. We are a fiercely passionate and committed team, driven to collaborate with thoughtfulness and respect. We value exceptional skills, scientific curiosity, entrepreneurial spirit, diversity and adaptability. #TogetherWeAreSolid in our mission to find a cure for Duchenne muscular dystrophy and we will not stop until we've done it. Solid Biosciences is looking for an Associate Director of Analytical Development with a strong background and hands-on experience in cell-based potency, binding/immunoassays, impurity assays to join the team. A successful candidate will help lead a motivated and collaborative team in defining new scientific approaches, facilitate method transfers, method qualifications, and validations. This individual will be responsible for analytical development, qualification, and operational support for Preclinical, Phase 1 through Phase 3 of clinical products for Solid Biosciences. Solid Biosciences' leading candidate is an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD). Key Duties & Accountabilities:

  • Lead a team responsible for the development, qualification and validation of bioassays/immunoassays including cell-based assays, binding assays, ELISAs, and PCR based analytics.
  • Plan and direct the development of novel analytical studies and strategies for characterization of AAV gene therapy products including functional characterization and potency development.
  • Management of analytical development bioassay activities at CTOs and CMOs, including deliverables and timelines; lead tech transfer of intellectual property, protocols/procedures and know-how from internal labs to QC and CMOs/CTOs, or between CMOs/CTOs, critically review data reports, batch records and certificates, continually review CMO/CTO performance to proactively identify issues and provide solutions to allow for consistently high quality assay performance
  • Provide SME oversight through Analytical & QC testing record review, method deviation assessment, OOO's/OOT's, and ultimately batch disposition.
  • Support all CMC filing activities for INDs, IMPDs, CTAs and BLAs and track analytical development /QC commitments.
  • Participate in BLA-enabling activities including product and process characterization, comparability studies, QTPP, TPP and CQA assessment activities
  • Author and/or critically review key documents such as: comparability protocols, methods and reports
  • Collaborate with process development, QA and QC functions to ensure strong cross functional collaborations and integrated process and product development and characterization
  • Build the scientific knowledge, capabilities, and strategies in bioassay/immunoassay product characterization that enable fast to clinic/fast to market product development and commercialization of efficacious and safe gene therapy products.
  • Excellent communication, technical, and organizational skills are required
  • Critical thinking, trouble-shooting, and attention to detail is a must
  • Strong leadership skills and ability to effectively manage a team of high performers
  • Ability to work collaboratively and across different functions in a fast-paced environment is required
  • Hands on Qualification/ Validation experience in compliance with regulatory requirements is required Knowledge, Education, Experience & Skills:
    • MS with at least 10 years experience or Ph.D. with 8 or more years of industry experience.; Gene therapy development experience a plus
    • Experience advancing a molecule from clinical to commercial desired
    • Hands-on experience developing potency assays in a variety of cellular systems required
    • Demonstrated experience in Bio/immunoassay development qualification, and/or validation according to USP/ICH guidelines
    • Experience working with Quality Control environment with an understanding of GMP regulations
    • Understanding of compliance and regulatory requirements, and trends related to product quality
    • Experience with authoring CMC sections of regulatory filings, interactions, BLAs
    • Demonstrated experience managing CRO/CTO/CMO's Travel Commitment: Some Travel May Be Required

Keywords: Loves Furniture, Cambridge , Associate Director, Analytical Development, Executive , Cambridge, Massachusetts

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