Director, Sterility Assurance
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Director, Sterility Assurance

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

The Center for Breakthrough Medicines Quality Assurance Department is seeking a Director of Sterility Assurance that will lead the Sterility Assurance Program and ensure compliance of aseptic manufacturing and testing operations, environmental monitoring and microbial control, as well as contamination control measures supporting Cell and Gene Therapy operations at the site. In addition, the Director of Sterility Assurance will be responsible for building impactful relationships and collaborations across the organization, in a highly regulated environment, to deliver exceptional service to our clients. If you have demonstrated experience of building and leading Sterility Assurance programs, then we encourage you to consider building your future with The Center for Breakthrough Medicines.

Responsibilities
  • Interpret industry regulations and guidance documents for the creation and implementation of strategies, standards, policies, and site procedures e.g., ISO 14644, Sterile Drug Products produced by Aseptic Processing-GMP, EU Annex1, EU Guideline-GMP Specific to Advanced Therapy Medicinal Products
  • Utilize background experiences, skill sets and expertise for the development and implementation of the site Sterility Assurance Program
  • Develop, document and manage microbial control strategy for GMP operations from incoming raw materials through final product release according into industry regulations
  • Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and EU aseptic processing requirements.
  • Conduct Risk Assessments for New Product Introduction into the site operations.
  • Collaborate with manufacturing and testing operations on the development of the Aseptic Technique Training and Qualification program.
  • Partner with internal and external vendors in the execution Environmental Monitoring Performance Qualifications (EMPQ).
  • Assess site programs, processes, and facility systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes
  • Data analysis- able to collect and analyze data to identify trends and detect problems and key issues
  • Judgement and problem solving- able to define decision criteria and determine the most appropriate course of action
  • Planning and organizational skills- able to establish objectives and schedule tasks and resources efficiently
  • Communication skills- strong written communication skills to provide concise and clear documentation
  • Partner with other business units or departments in support of continuous improvement initiatives
  • Develop or revise SOPs to address gaps or necessary improvements to Quality Systems
  • Develop and provide cGMP and other GxP training as needed
  • Provides microbiological expertise to support Action and Alert Investigation, deviations, CAPAs and complaints related to aseptic processing
  • Supports regulatory and client audits as Aseptic Sterility Assurance subject matter expert
  • Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications

Qualifications

  • Bachelor’s Degree in Life Sciences, Chemical Engineering or related discipline
  • Advanced degree is desirable
  • 10+ years of experience in pharma/biotech industry, min 5-7 years of aseptic /sterile processing experience in a GMP environment
  • Cell and Gene Therapy experience a plus
  • Knowledge/experience of analytical methods relevant for microbial control
  • Experience in microbiology sterilization validation terminal aseptic and or reprocessing and environmental controls for a pharmaceutical manufacturing facility
  • Proven track record on troubleshooting process non conformances and out of specification test results and providing resolution to issues by a robust CAPA process 

Compensation: TBD

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