DNAtrix
  • San Diego, CA, USA
  • Full Time

The Sr. Manufacturing Manager is responsible for providing oversight on GMP manufacturing activities at CDMOs for DNAtrix's adenovirus-based products for our clinical programs. This position reports to the SVP of Manufacturing and is remote based.

Specific Responsibilities: 

  • Tracks CDMO and other vendor activities, including adherence to timelines and budgets to ensure timely release and distribution of clinical supplies to global distribution sites
  • Works in a cross-functional team consisting of internal and external partners to ensure effective execution of projects at CDMO including technology transfer, process characterization, process validation and GMP manufacturing
  • Reviews batch production records and testing reports; coordinates with QA unit for product release
  • Reviews process characterization reports, assists with process validation activities at CDMO
  • Initially, will assist with managing quality control testing, method validation activities and stability studies with outside vendors
  • Assists with collating data and writing sections for world-wide regulatory submissions
  • Generates and reviews SOPs and other quality documents for monitoring and overseeing manufacturing, quality control testing, and stability studies with external vendors
  • Builds and maintains collaborative working relationships with internal/external stakeholders; ensures communication channels are operating optimally for successful outcomes
  • Domestic travel required to DNAtrix's San Diego office and CDMO/CRO sites (15%)

Qualifications: 

  • Bachelor's degree in a scientific discipline with 6+ years of experience in the biotech/pharmaceutical industry. Master's degree preferred.
  • Experience working with external CDMOs
  • Working knowledge of GLP/GMP practices
  • Project management experience
  • Prior work experience in oncolytic viruses/gene therapy highly desired

Competencies:  

  • Excellent written and verbal skills; strong technical writing skills
  • Strong attention to detail
  • Ability to work independently with minimal supervision
  • Effective problem-solving and analytical skills; results oriented
  • Ability to navigate ambiguity and changing priorities; flexible
  • Quality conscious approach in daily work activities
  • Strong project management skills
  • Successful experience in fast-paced entrepreneurial environments
DNAtrix
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