External Manufacturing Manager

Corvallis, Oregon
Feb 14, 2018
Required Education
Bachelors Degree
Position Type
Full time

Apex Life Sciences has a permanent opening for External Manufacturing Manager for Our Client, a groundbreaking pharmaceutical company, located in Oregon.  The successful candidate will be responsible for the day-to-day management of an expanding Contract Manufacturing Organization (CMO) supply chain and therefore must have experience with external vendor management. 


Description of Duties:

  • Provides technical expertise in management of a pharmaceutical manufacturing supply chain from drug substance to drug product to packaging and delivery to customer.
  • Identifies project risks and gaps and works to mitigate those risks. 
  • 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 during active manufacturing at vendor locations
  • Addresses problems and deviations as they arise at the manufacturing sites and assists in implementing corrective and preventative actions.
  • Prepares and presents documentation for BARDA communications and internal management reviews.
  • Works closely with Our Client’s Project Management Team in the reporting of supply chain status.
  • Evaluates CMO performance, reviews batch manufacturing records, deviations and investigations.
  • Maintains understanding of current trends in drug product manufacturing and engineering research.
  • Maintains understanding of current FDA guidance related to CMC activities.
  • Attends regularly scheduled meetings with Our Client’s Customer(s), upper management and internal project teams.


Job Qualifications:

  • A minimum of five years of pharmaceutical supply chain experience including commercial production
  • Advanced Degree in pharmaceutics, chemical engineering, chemistry or a relevant field.
  • Broad knowledge and experience with regulatory requirements including ICH, FDA and compendia USP, JP, EP.
  • Experience in preparing data for presentations and publications.
  • Management experience in a pharmaceutical / biotech industry setting.
  • The ability to function in a fast-paced, high-growth, entrepreneurial environment.
  • Strong regulatory knowledge of drug development, CMC, preclinical and clinical requirements.
  • Experience with antiviral or anti-infectious drugs a plus.
  • Travel domestically and internationally will likely be required.