External Manufacturing Manager in Corvallis, OR at Apex Life Sciences

Date Posted: 4/14/2018

Job Snapshot

Job Description

External Manufacturing Manager

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.

contact: Daniel | dyun@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.


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