Deerfield Management Companies

  • Director of Process Engineering

    Job Locations US-OH-Columbus
    Posted Date 1 month ago(10/18/2018 2:15 PM)
    ID
    2018-1105
    # of Openings
    1
    Category
    Engineering
  • Overview

    Sollis Therapeutics is currently recruiting for a Senior Director of Process Engineering.  The preferred location is Columbus, OH.

    Sollis Therapeutics is a clinical stage specialty pharmaceutical company developing innovative non-opioid pain therapies to treat important pain conditions.  The lead program is in late stage clinical development and the CMC program is focused on validation and establishment of the commercial supply chain. 

    The role, Director, Process Engineering, will be responsible for Supply Chain activities across the portfolio including validation of manufacturing process and monitoring installation and maintenance of manufacturing equipment. The ideal candidate will be familiar with hot melt extrusion processes and automated manufacturing assembly equipment.  The candidate should be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

     

    Summary of Position:

    • This position is the key driver of the manufacturing strategy and execution
    • The position also will work closely with the Sollis employee project teams

    Qualifications

    Education, Experience, Skills and Knowledge:

    • Advanced degree in chemical or process engineering
    • 5+ years experience in corporate / academic setting, preferably in the pharmaceutical industry or other life sciences setting
    • Excellent written and verbal communication skills
    • Experience with CAD and 3-drawing programs
    • High degree of proficiency with Microsoft Office software, especially Word and Powerpoint
    • Demonstrated ability to follow processes and procedures
    • Work autonomously in executing on directives
    • Demonstrated ability to think critically, identify and solve problems
    • Excellent time management skills and ability to multitask
    • Attention to details and significant coping skills as required to thrive in a startup environment
    • Proven ability to interact well in a multifunctional team setting
    • Can do attitude, flexibility, and mental agility

     

    Sollis Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

     

    PM18

    Responsibilities

     

    • Overall responsibility for commercial manufacturing of solid, hot-melt extrusions.
    • Strong knowledge and experience in aseptic manufacturing, implantable drug-delivery and device technology is required
    • Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP)
    • DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP
    • Delivery of robust, scalable and cost-effective manufacturing routes that are commercially feasible
    • Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
    • Establishes and maintains relationships with all Sollis manufacturing vendors

     

    Interactions with other functions:

    Maintains an excellent working relationship with all internal Sollis team members to insure drug supply coordinates with the other aspects of the development plan

     

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