• Product Development Manager

    Posting Date 3 months ago(5/18/2018 5:42 PM)
    Requisition ID
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Cook Myosite Inc.
  • Overview

    The Product Development Manager at Cook Myosite is responsible for overseeing all departmental functions in support of new and ongoing product and manufacturing process development of cell therapy products.


    • Ensures resources are available and efficiently utilized to perform core departmental functions
    • Ensures and maintains open communication with other departments for realization of department and company goals
    • Supports the discovery and development of new products and processes, and expanded indications/uses for existing products
    • Acts as a resource to provide direct technical and scientific support to department and company projects
    • Where needed, develops scientific and technical expertise and capabilities as necessary for project management and completion
    • Ensures the accuracy and completeness of technical and scientific reports and presentations for internal and external use
    • Assists in the evaluation and transfer of new technology and processes

    • Strengthens and supports the development of intellectual property
    • Ensures accuracy and integrity of scientific work performed within department
    • Assists in data analysis, data summary and interpretation of results, and formulation of appropriate recommendations
    • Works with executive management to align strategic objectives and priorities, and establish timelines in support of new and ongoing department projects
    • Participates in the hiring, development, retention and optimal performance of staff for the leadership and execution of operations



    • Bachelor's degree in Life Sciences or Engineering at minimum; advanced degree preferred
    • 5+ years of experience managing and leading projects or relevant experiences within the biopharmaceutical or healthcare industry
    • Demonstrated experience and knowledge of cGMP and GLP
    • Ability to exercise sound judgment in conducting and interpreting scientific research
    • Must possess excellent organizational skills and the ability follow complex processes, procedures and systems

    • Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager
    • Proficiency in MS Office and other general office equipment
    • Must maintain a high level of professionalism, business acumen
    • Must have effective verbal, written and interpersonal skills
    • Maintain composure and competence under stressful situations; flexibility and adaptability 
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing


    Physical Requirements:

    • General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
    • Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
    • Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting
    • Ability to conduct and hear ordinary conversation and telephone communication

    • Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
    • Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis


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