Drug Product Manager, Process Development
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Drug Product Manager, Process Development

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

Center for Breakthrough Medicines is seeking an experienced scientist to fill the Drug Product Manager role within the Process Development Department. The Drug Product Manager, Process Development will be a laboratory-based role, operating independently and within a cross-functional team to progress the clients’ Gene therapy programs and projects. The candidate will be a self-starter responsible for leading, designing and performing experiments in support of formulation and fill-finish activities for various modalities of advanced therapies.

Responsibilities

  • Design and execute phase-appropriate studies in support of formulation selection and drug product manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing, sterile filtration, and filling
  • Design and execute in-use stability and compatibility studies to support clinical administration of novel advanced therapies
  • Set-up and lead stability studies and data interpretation
  • Organize and participate in technical discussions aimed at resolution of issues with suppliers, processes, and deviations
  • Prepare technical reports and present the finding to colleagues and management
  • Supervise, guide, and mentor junior scientists within the drug product process development team
  • Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
  • Follow general laboratory safety and training requirements

Qualifications

  • BS in Biological, Pharmaceutical sciences, Engineering or Chemistry with 8+ years’ work experience, or MS with 6+ years’ work experience, or PHD with at least 1 year work experience
  • Biologics, vaccine, or gene therapy development experience
  • Experience with characterization of biological molecules, including biochemical, biophysical and/or analytical methods such as particle analysis, fluorescence and UV spectroscopy, dynamic or static light scattering and separation methodologies
  • Ability to interpret and analyze data from analytical assays and design appropriate experiments
  • Excellent written and verbal communication skills
  • Ability to use scientific literature to support novel projects and/or experimental data
  • Management experience preferred
  • Proven publication and presentation history preferred

Compensation: TBD

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