GMP Technical Writer, Vector Manufacturing
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GMP Technical Writer, Vector Manufacturing

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

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 

Competencies

  • Effective technical writing and communication
  • Highly proficient in Microsoft Word and other Microsoft Office systems.
  • cGMP knowledge or manufacturing or process development background preferred.
  • This is a dayshift position, reporting M-F however the candidate must be able to be flexible to support critical timelines.
  • This position can be hybrid (WFH and limited on-site support) or remote for the right candidate.
  • Limited shopfloor support may be required and the candidate must be comfortable with Clean Room gowning and can access and walk the floor if needed to research and collaborate as needed. 

Compensation: TBD

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