Director of IV Manufacturing/Development in Corvallis, OR at Apex Life Sciences

Date Posted: 4/14/2018

Job Snapshot

Job Description




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.

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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