• Product Development Manager

    Posting Date 3 months ago(5/18/2018 5:42 PM)
    Requisition ID
    2018-4529
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Biomedical/Biotechnology
  • 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.

    Responsibilities

    • 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

     

    Qualifications

    • 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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