Radius Health, Inc.

  • Director, Analytical Development

    Job Locations US-PA-King of Prussia | US-MA-Waltham
    Posted Date 3 weeks ago(8/3/2018 1:06 PM)
    Job ID
    2018-1813
    # of Openings
    1
    Category
    Pharmaceutical Sci - Dept
  • Overview

    Radius Health is searching for a Director, Analytical Development, Tech Ops. With sound technical and leadership capabilities this person will develop our promising pipeline and support our commercial products. The successful candidate will lead analytical activities for projects at various stages of clinical development, helping our osteoporosis and oncology franchises bring innovative therapies to patients. Key technical responsibilities include serving as the subject matter expert for drug substance and drug product analytical methods development, transfer, validation, material specifications, and stability.

    This role will work collaboratively within Technical Operations and internal project teams including Drug Substance, Drug Product, Supply Chain, Quality, and Regulatory, and with external contract organizations as well.

    This position reports to the Senior Vice President, Technical Operations.

    Responsibilities

    • Manage development and implementation of analytical methods at contract laboratories for release and stability testing for drug substance (small molecule and peptide) and drug product (solid oral and combination products)
    • Participate in selection of third party testing laboratories, and oversee phase-appropriate method validation, method transfer, testing plans, and data receipt
    • Provide input into experimental design and critically review process development documentation
    • Review and interpret analytical data for drug substance and drug product, and effectively communicate results
    • Establish phase-appropriate specifications and control strategies for materials, design studies to support late-phase specification development, and author justification of specification documents
    • Manage formal and informal stability studies, apply statistical methods of analysis, and guide project team activities based on stability outcomes
    • Work closely with Quality to assess and approve method change controls, investigate OOS and OOT test results, and assure that corrective actions are implemented
    • Author and review regulatory documents (IND, IMPD, NDA, DSUR) and support regulatory submissions and responses
    • Lead analytical activities for programs at all stages of development, and represent the Analytical Development function on cross-functional CMC teams
    • Collaborate effectively with the Drug Substance, Drug Product, Supply Chain, Quality, and Regulatory groups to meet program goals
    • Be knowledgeable about the current CMC regulations applicable to the pharmaceutical/biotechnology industry

    Qualifications

    • Ph.D. in chemistry with 10 or more years of relevant experience in pharmaceutical analytical methods development and validation, or M.S. in chemistry with 12 or more years of relevant experience
    • A track record in leading analytical development activities in various stages of development;
    • Deep practical experience in separation techniques and detection methods, including reverse phase, normal phase, ion exchange, and size-exclusion chromatography;
    • A well-grounded foundation in other analytical techniques such as MS, NMR, UV and IR spectroscopy, with strong understanding of the underlying principles;
    • Familiarity with methods for physicochemical characterization (XRPD, DSC, TGA) preferred;
    • Experience with sterile dosage forms preferred;
    • Strong oral and written communication skills, with experience in preparing stability and validation protocols, technical reports, and regulatory filings;
    • Knowledge of regulatory and compendial guidance (GMP, GLP, ICH, USP) and practical experience in meeting requirements in a phase-appropriate manner;
    • Experience working and maintaining relationships with external contract organizations, and demonstrated ability to build and manage relationships with business partners;
    • Ability to manage collaboratively across diverse functions, operate independently, and build strong networks throughout the corporate organization;
    • Ability to prioritize and align functional activities with goals and objectives, and ensure operational excellence.

     

    Work Environment

    The work is performed in a typical office environment with heavy computer duties.  The noise level in the work environment is usually quiet.  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

     

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

     

     

     

     

     

     

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