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Technical Writer-TEMP

King of Prussia, PA, US
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    Summary

    · Support execution of New Product Programs and Continuous Improvement projects within the Viral Vector platform at the Center for Breakthrough Medicine.

    · Supporting all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make CBM a best in class CDMO facility.

    · Candidate must be prepared for an exciting, dynamic, and fast paced CDMO/start up environment.

    Responsibilities

    · Development and revision of Master Batch Records, Work Instructions, Logbooks, Forms and Standard Operating Procedures to support Vector Manufacturing.

    · Authoring and creating documents associated with New Products Programs and Continuous Improvement Projects and deliverables for VV.

    · Authoring and creating documents associated with the initial stand up of the organization.

    · Maintain a culture of Safety, Quality, Delivery, and Operational Performance based on CBM Goals and Vision.

    · Maintain Cost Mindfulness and promote Innovation and Team work to meet or exceed Revenue and EBITDA targets.

    · Focus on Client Success and Transparency with each program.

    · Communicate effectively and timely to address internal and client comments ensuring the document content meets the intention and required details to be successful.

    · Participate as a key member of Program Project Teams to complete deliverables On Time in Full.

    · Escalate issues that would jeopardize the Program Timeline and milestones.

    · Work Cross-functionally on project team and work closely with the shop floor to ensure documents are meaningful.

    · Development of Batch Records, SOPs, Training Modules for tech transfer projects and internal vector CAPAs, deviations, and continuous improvement objectives.

    · Work closely with process SMEs to execute on Time Technical Transfer of new or optimized programs by ensuring documents are completed and correct.

    · Support Quality Audits, Supplier Audits, and Regulatory Inspections.

    · Follow Operational Excellence Standards with department

    · Manage and track assigned documents through the entire life cycle (i.e. creation, review, revision, approval) using detailed project planning to meet project milestones.

    Qualifications

    ·The ideal candidate is preferred to have a Bachelors Degree in a technical or applicable discipline or equivalent.

    ·The Ideal candidate is preferred to have 2+ years experience or equivalent.

    ·Regulatory experience with FDA, EU commercial and Clinical is a plus.

    ·Knowledge of quality systems or document control systems a plus.

    ·Strong Cross Functional Communication skills.

    ·Technical Skills and Experience preferred for the role:

    ·Technical Transfers

    ·Project Planning

    ·Document Creation

    ·Quality document creation and management

    ·Problem Solving

Technical Writer-TEMP

King of Prussia, PA, US
Apply Now >