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Biologist I

K3 Innovations

  • NULL, NULL
  • 7 days ago
  • Remote

    Highlights

    As part of the PDS&T Biologics organization, MSAT leads the process technology transfer, optimization, validation, implementation, and continuous process improvement for late-stage and commercial manufacturing of therapeutic proteins. BS/MS degree in a scientific or engineering discipline with 0-2 years related industry experience Knowledge, Skills and Abilities: Knowledge of applicable regulatory authority, compendia and ICH guidelines.

    Numbers & Facts

    LocationNULL, NULL (
    Remote
    )

    Description

    Description:

    Number of Positions Needed

    2

    Length of Initial Contract

    6 months (with potential extensions)

    Location/Site

    Bioresearch Center, Worcester, MA

    Type of role:

    100% Remote | 100% Onsite | Onsite Hybrid (# of days onsite required)

    100 % Onsite

    Cost Center:

    0000636519

    Reason for Request

    Support of increasing number of late-stage pipeline activities

    Daily Work Schedule Expectations

    8 hrs/day, 5 days a week, weekend work as necessary

    Budget Approval Obtained (Yes/No)

    Yes

    Top 3 5 Skills Needed for each role

    1. Ability to work well both independently and in teams

    2. Strong written and oral communication skills

    3. Demonstrated problem-solving skills and capability to overcome complex issues

    4. Must have a "results-oriented" work ethic and a positive "can-do" attitude with a strong sense of urgency and self-motivated desire to achieve

    5. Ability to utilize Microsoft Excel and Word to perform tasks

    Travel Required: Y/N

    N

    Number of Interviews (recommend to minimize)

    2 for each contractor

    1. Matthew Billups/Wen Chung Lim/Sean McDermott

    1. Matthew Noel/Scott Fredricksen

    Job description:

    We are seeking a highly motivated Biologist I/II to join the Manufacturing Science and Technology (MSAT) department at Bioresearch Center based in Worcester, MA.

    As part of the PDS&T Biologics organization, MSAT leads the process technology transfer, optimization, validation, implementation, and continuous process improvement for late-stage and commercial manufacturing of therapeutic proteins. We also provide technical support for manufacturing, GMP compliance, and regulatory filing.

    Our mission is to support manufacturing and drive and implement improvement of processes and technologies for commercial products to deliver quality, compliance, financial and innovation goals for the benefit of our customers.

    Key Responsibilities Include:

    • Providing technical support to late clinical stage and commercial biologics manufacturing processes
    • Supporting lab scale studies relevant to late clinical stage and commercial biologics manufacturing processes
    • Support the writing and data review of official documentation relevant to late clinical stage and commercial biologics manufacturing processes
    • Data monitoring and trending for continuous process verification
    • Applying GMP and GLP principles to all aspects of work and documentation

    Qualifications

    Education and Experience:

    • BS/MS degree in a scientific or engineering discipline with 0-2 years related industry experience Knowledge, Skills and Abilities:
    • Knowledge of applicable regulatory authority, compendia and ICH guidelines
    • Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
    • Ability to utilize Microsoft Excel and Word to perform tasks
    • Good written and oral communication skills
    • Time management and project management skills
    • Problem solving and troubleshooting abilities
    • Ability to work in a collaborative work environment with a team
    • Strong organization skills with high attention to detail
    • Aseptic handling experience desirable
    • Coding experience or advanced excel capabilities desirable

    Enable Skills-Based Hiring No
    Provide the days of the week and the hours that this position will require:

    Additional Details

    • Manager's Requested NA : (No Value)
    • Does the position allow for the worker to be virtual/remote? : No
    • Shore Options Available for this Position : Onshore Only
    • Provide the days of the week and the hours that this position will require: : (No Value)

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