Director of IV Manufacturing & Development

Corvallis, Oregon
Feb 14, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Director of IV Manufacturing & Development

Apex Life Sciences has a permanent opening for Director of IV Manufaturing/Development for Our Client, a groundbreaking pharmaceutical company, located in Oregon.  This position will report directly to the SVP of Drug Development/Manufacturing.  As a leader of this functional area, the Director of IV Manufacturing/Development will shape manufacturing processes and strategies to meet regulatory requirements and company needs.  

Description of Duties:

  • Provides technical expertise to manufacturing process transfers, scale-up and validation.  Especially within the area of parenteral product development.
  • Develops and implements a comprehensive QbD plan for commercial process scale-up.
  • Develop project risk strategy, identify gaps and mitigate risks.  Ensure a validation plan and QbD is inclusive, complete and supportive for successful regulatory submissions.
  • Communicates effectively and transparently with functional heads within Pharmaceutical Development, Quality, Regulatory, Project Management and Operations.
  • Communicates effectively and productively with responsible team members from manufacturing partners (CMOs).
  • Provides on-site support and coordinates Our Client's man-in-plant activities in support of process scale-up, validation and commercial manufacturing at CMOs.
  • Support Pharma Development team with product design and formulation development as these activities may be impacted during process transfer and scale up.
  • Develop, review and approve process validation protocols, method transfer and advise on in-process testing.
  • Prepare and review documents for IND, IND amendments, NDA and other types of regulatory submissions.
  • Prepare and present documentation for BARDA communications and internal management reviews.
  • Works closely with Our Client’s Project Management Team in the reporting of data, study progression and next steps.
  • Evaluate CMO performance, review batch manufacturing records, deviations and investigations.
  • Maintain understanding of current trends in drug product manufacturing and engineering research.
  • Maintain understanding of current FDA guidance’s.
  • Attend regularly scheduled meetings with Our Client’s Customer(s), upper management and internal project teams.
  • Attend meetings with the FDA if needed.

Job Qualifications:

  • A minimum of ten (10) years of pharmaceutical industry background in process development & scale-up.
  • A minimum of six (6) years in commercial productions, with emphasis on IV.
  • An advanced degree in pharmaceutics, chemical engineering, chemistry or relevant field.
  • Broad knowledge and experience with regulatory requirements including ICH, FDA and compendia USP, JP, EP.
  • Successful write-up of CMC sections for IND and NDA submission experience.
  • Management experience in pharmaceutical/biotech industry setting.
  • Regulatory interaction and government contract experience.
  • The ability to function in a fast-paced, high-growth, entrepreneurial environment.
  • Experience with antiviral or anti-infective drugs a plus.
  • Domestic travel up to 25% of the time will likely be required.