Assoc Dir,Ops & Proc Readiness , CC
FujiFilm Diosynth Biotechnologies - Durham, NC

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Job Description:
The successful candidate will direct all introduction
efforts related to API manufacturing. This includes
responsibility for overseeing, facilitating, approving,
managing feedback loops and archiving lessons learned
for the introduction of processes (including operators,
methods, equipment and materials) involved with API
manufacturing into the RTP facility. This includes
ensuring the effective use of resources to meet
committed manufacturing schedules while maintaining
compliant operations.

Main areas of responsibility include:
  • In cooperation with PD, Tech Ops, CPM, and Quality,
ensures development and manufacturing schedules that
meet the company's revenue projections
  • Ensures and develops tools to allow personnel,
process and equipment introductions are robust and
effective in order to meet revenue projections with
a right first time perspective
  • Resposible for assuring manufacturing is performed
within cGMP requirements
  • Ensure all areas of responsiblity follow cGMPs and
meet appropriate regulatory requirements
  • Ensure all areas comply with required safety
procedures and that personnel attend safety training
FUJIFILM Diosynth is an equal opportunity employer,
M/F/D/V

Required education and experience:
  • Bachelor's degree in a related scientific or
engineering discipline and 10+ years' related
experience or 15+ years of directly related
experience
  • Experience should include development, quality and
production in the biopharmaceutical industry with a
demonstrated increase in responsibility

Required skills:
  • Facilitation, presentation and organizational skill
  • Technical and pharmaceutical operational knowledge
  • Process, Instrumentation, and Controls knowledge
  • Lead Six Sigma Green Belt/Black Belt or ability to
ascertain within 12 months
  • Potential problem and risk analysis tools
  • Manufacturing systems knoweldge including Work
Instructions, Batch Records, Automation recipes,
checklists, etc
  • Quality Systems knowledge
  • Training Systems knowledge
  • Critical Thinking
  • Leadership skills with particular focus:
Set root cause analysis and error reduction
directino and inspire others to work towards
that direction
Utilize inclusive behaviors
  • Communication Skills
Convey meaningful information
Make problems visible, solve them
collaboratively
Embrace the tier process and visual management
Negotiate to a resolution

FujiFilm Diosynth Biotechnologies - 23 months ago - save job
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