• Analytical Method Development Scientist

    Posting Date 3 months ago(2/27/2019 3:46 PM)
    Requisition ID
    2019-6049
    Job Location(s)
    Pittsburgh PA United States
    Travel
    Less than 10%
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Scientific
  • Overview

    Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply below.

     

    The Analytical Method Development Scientist at Cook Myosite Inc. will be responsible for developing analytical methodologies to support the development of cellular therapy products treating a range of muscle-based conditions and diseases.  This is a predominantly laboratory based role, with expectations to perform experimental work in accordance with industry best practices and external regulatory requirements for method development and validation. 

     

    Responsibilities

    ·       Provide continual development of analytical methodologies and control strategies to characterize cell-based products, using techniques such as flow cytometry, PCR, fluorescence-based imaging and more

    ·       Assists in all areas of analytical method development, including discovery, design, development, improvement, implementation, pre-validation, and validation support

    ·       Identifies and evaluates new methods, related equipment and technology for assessing process and product quality characteristics

    ·       Acts as a resource to provide technical and scientific troubleshooting support to company departments, as needed, in area(s) of expertise

    ·       Assists in the evaluation and transfer of new technology and analytical methods

    ·       Works with department management to identify and develop objectives and timelines in support of new and ongoing development projects

    ·       Where needed, develops scientific and technical expertise and capabilities as necessary for project completion

    ·       Prepares technical and scientifically accurate reports and presentations for internal and external use

    ·       Strengthens and supports the development of intellectual property

    ·       Performs research, analyzes and summarizes data, participates in the interpretation of results and formulation of appropriate recommendations

    ·       Effectively tracks and communicates with department management regarding project progress and milestones via regular meetings, scientific presentations and/or written reports

    ·       Maintains work area including maintenance and operation of equipment, and preparation and sanitization of work areas where appropriate

    ·       Maintain regular and punctual attendance

    ·       Must maintain company quality and safety standards

    ·       Exemplifies Cook MyoSite Core Values

    Qualifications

    ·       Bachelor's degree with 5+ years related industry experience, or graduate degree (MS or PhD) with 3+ years related industry experience in analytical methods development for biopharmaceutical or related products

    ·       PhD in biological sciences or relevant field is preferred

    ·       Experience in late phase biologic/drug development is preferred

    ·       Knowledge of the regulatory environment, particularly guidelines on analytical method development and validation and application of compendial methods and standards

    ·       Broad experience with cell-based assays

    ·       Must be independent and able to proactively apply knowledge in the design, execution and qualification of analytical methodologies

    ·       Ability to effectively document and communicate results

    ·       Trainability

    ·       Excellent organizational skills and the ability and willingness to handle multiple projects and responsibilities

    ·       Must work and interact effectively with others in a team setting

    ·       Must maintain a high level of professionalism and business acumen in all situations

    ·       Proficient in MS Office and other general office equipment

    ·       Work collaboratively or independently depending on the situation, with minimal supervision

     

    Physical Requirements:

    ·       Must be able to sit at desk, in meetings and/or work on a computer

    ·       Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending

    ·       Majority of some days spent on feet in warehouse setting

    ·       Frequent climbing a mobile ladder and/or other types of ladders

    ·       Must be able to lift/push/pull 50 pounds

    ·       Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II

    ·       Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

    ·       Must perform PPE gowning procedures on a daily basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position

    ·       Ability to work under specific time constraints

    ·       Laboratory, warehouse and office setting


     

     

     

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