• Associate Scientist II, Technical Transfer

    Job Locations US-WI-Madison
    Req No.
    2019-3171
    Category
    Manufacturing Operations, Facilities & Security
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Associate Scientist II, Technical Transfer role will assist in a variety of technical transfer and continuous improvement activities facilitating process and product transfer into Operations.  This position will develop, document, validate, and implement new processes and procedures into production as part of the design transfer process.

    Essential Duties and Responsibilities

    • Assist in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines
    • Define, characterize, and proceduralize Critical Process Parameters (CPP), Proven Acceptable Ranges (PAR), and critical control points as an output of process design
    • Establish Production Work Instructions, Receiving Inspection Methods, Technical Summary Reports, Standard Operating Procedures, and other technical and GMP manufacturing documents as required
    • Support processes and demonstrate capability through execution of development, pilot scale, and process validation batch production
    • Identify, source, and characterize novel manufacturing equipment
    • Support training and transfer of new processes and procedures to production operators
    • Work externally to understand raw material sourcing, specifications, and risks in collaboration with R&D and Supply Chain teams
    • Act as project team member for key business initiatives and continuous improvement projects
    • Participate in investigations and risk assessment activities including pFMEAs
    • Support, comply with, and continuously improve the company’s Quality Management System policies and procedures
    • Work collaboratively with Production, R&D, Quality Engineering, Regulatory, Supply Chain, and other cross-functional areas as necessary
    • Perform other related duties and special projects as assigned by management
    • Ability to use computers daily in an interactive manner for extended periods of time
    • Ability to sit for an extended period of time
    • Ability to frequently and accurately communicate with employees in person, via the telephone or by email
    • Ability to lift and move up to 40 pounds on an occasional basis
    • Ability to work with blood, tissue, stool or other human specimen samples
    • Support and comply with the company’s Quality Management System policies and procedures

    Qualifications

    Minimum Qualifications

    • Bachelor’s degree in Life Sciences or related field; or high school degree/general education diploma and 4 years of relevant experience in lieu of degree
    • 2+ years of relevant experience
    • Familiarity with database, spreadsheets, and statistical programs such as JMP
    • Knowledge and experience working within a CFR 820, ISO 13485, ISO 12207 and/or cGMP structured environment
    • Proficient in a variety of common laboratory skills and techniques with a base knowledge in chemistry, biochemistry, molecular biology, or a related field
    • Understanding of IVD product manufacturing processes, Biochemical, Molecular & Real-Time-PCR Assays
    • Ability to design basic experimental plans and interpret technical data
    • Ability to effectively work on several varied projects at one time, with frequent changing priorities
    • Strong analytical and problem-solving skills
    • Ability to effectively communicate with multi-level personnel as well as outside vendors and their representatives
    • Proven ability to work effectively in team situations as well as independently. Able to collaborate across functions and within a workgroup to meet business objectives
    • Excellent oral and written, communication, interpersonal, and presentation skills. Strong attention-to-detail
    • Ability to prioritize tasks and adhere to project schedules and timelines in a fast-paced, frequently changing, and evolving environment
    • Ability to travel as needed
    • Authorization to work in the United States without sponsorship

    Preferred Qualifications

    • 2+ years of experience with medical device products in a cGMP manufacturing and/or technical role
    • Hands-on experience in molecular biology, biochemical, and IVD product manufacturing techniques
    • Knowledge in design for Six Sigma and Statistics
    • Knowledge in continuous improvement methodologies / principles such as LEAN Six Sigma
    • Experience with project management principles and practice

    #LI-MF1

    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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