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Technical Writer-TEMP

King of Prussia, PA, US
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    · 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.


    · 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.


    ·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 >