Senior Director, Analytical Development

Company: Flagship Pioneering, Inc.
Location: Cambridge
Posted on: January 9, 2021

Job Description:

Company Summary:LARONDE is an early-stage biotechnology company with the mission to become the leader in the development of nucleic acid medicines by leveraging its multi-modality eRNA platform. LARONDE has established a powerful technology exploiting the properties of naturally occurring eRNAs allowing the development of therapies with exceptional precision and durability of expression to address unmet needs across multiple disease areas.LARONDE was founded by Flagship Pioneering, a team of entrepreneurial scientists that conceives, creates, resources and grows first-in-category life sciences companies. Since 2000, Flagship has created over 100 groundbreaking companies pioneering novel and proprietary biological, industrial and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna Therapeutics (MRNA), Seres Therapeutics (MCRB), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Evelo Biosciences (EVLO), Kaleido Biosciences (KLDO) and Indigo Agriculture.Position Summary:LARONDE is seeking a Sr. Director in Analytical Development to join our team to advance the science of pioneering novel insights into nucleic acid modalities to develop therapeutic hypotheses from technology validation to target discovery and beyond. The successful candidate will join the Technical Development Group dedicated to early- stage development of nucleic acid therapeutics and contribute to ongoing efforts to analytical methods and the exploration of new techniques for the elucidation of structure and for the measurement of purities and related substances.A background in nucleic acid chemistry / biology and knowledge of the molecular components involved with mRNA production will be highly valued. Candidates with experience and training in analytical chemistry, biochemistry, oligonucleotides, mRNA modality development and characterization and high-throughput techniques will be preferred. The candidate must be independent, goal-oriented, able to efficiently lead teams, and complete multiple projects in parallel. The position will require creativity, resourcefulness, and adaptability. We are searching for enthusiastic, innovative, and highly motivated individuals who are comfortable working in a fast-paced entrepreneurial environment.Responsibilities:

• Technical lead for GMP method development, validation, method transfer, data analysis and reporting to ensure compliance with GCP, GLP and cGMP standards
• Author and review assay development and validation reports, relevant sections of documents pertaining to analytical methods development and documentation for submission to regulatory agencies.
• Act as a CMC lead in analytical development team, lead the design and execution of comparability and stability studies for multiple programs
• Provide subject matter expertise and leadership in developing analytical methods for product release testing and product characterization
• Work closely with research team to transfer assays to process development group for qualification and validation
• Lead strategy and initiatives for analytical team, support in-process assays for process and formulation development
• Effectively collaborate with a fully integrated process development and other teams
• Additional duties and responsibilities as requiredQualifications:
  • M.S./PhD or equivalent in a relevant biological discipline and at least 10 years of relevant pharmaceutical industry experience
  • Deep knowledge of analytical assay development, qualification and validation requirements to comply with current regulatory standards
    • Experience in directing the development and validation of molecular biology test methods not limited to PCR (qPCR, ddPCR), LC/MS, ELISA, SDS-PAGE, AUC, and cell-based potency assays
    • Proficient in relevant analytical methodology, emerging new technologies, troubleshooting and problem solving
    • Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD and BLA
    • Working knowledge of Good Laboratory Practices (GLP)
    • Familiarity with formulation development for Biologics or, gene therapy development
    • Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
    • Demonstrated capacity to work in a fast-paced environmentFlagship Pioneering is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

Keywords: Flagship Pioneering, Inc., Cambridge , Senior Director, Analytical Development, Executive , Cambridge, Massachusetts