Assoc Dir, Problem Analysis CC
FujiFilm Diosynth Biotechnologies - Durham, NC

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Job Description:
In this position, the successful candidate will direct
all problem solving, failure analysis and corrective
action implementation and sustainability efforts related
to API manufacturing. They will be responsible for
overseeing and facilitating the failure mode analysis
related to operator, methods, equipment, materials and
environment involved with API manufacturing. This
includes ensuring the effective use of resources to meet
committed manufacturing schedules while maintaining
compliant operations, effectively solving problems,
improving operations, reducing defect and error modes,
and implementing sustainable countermeasures. This
person will be responsible for the human error
reduction, data management and operational improvement
initiatives and metrics involving manufactuing.

Main areas of responsibility include:
  • In cooperation with PD, Tech Ops, CPM, and Quality
ensure development and manufacturing schedules that
meet the company's revenue projections
  • Ensure and develop tools to allow personnel, process
and equipment root cause investigations and process
improvements are robust and effective in order to
meet revenue projections
  • Manages product and process trend reports and drives
improvement needs and initiatives to optimize
manufacturing processes and consistency
  • Responsible for assuring manufacturing is performed
within cGMP requirements
  • Ensure all areas of responsiblity follow cGMPs and
meet appropriate regulatory requirements
  • Ensure all areas of responsibility comply with
required safety procedures and that personnel attend
safety training
FUJIFILM Diosynth is an equal opportunity employer,

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 should include development, quality and
production in the biopharmaceutical industry with a
demonstrated increase in responsibility

Required skills:
  • Facilitation, presentation and organization 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
  • Root cause analysis tools such as FEMA, HACCP, KT
  • Control Charting and data management knowledge
  • Quality Systems knowledge, utilization of CAPA
  • Human Error Reduction knowledge
  • Critical Thinking
  • Communication Skills
Convey meaningful information
Make problems visible, solve them
Negotiate to a resolution
  • Leadership skills with particular focus:
Set root cause analysis and error reduction
direction and inspire others to work towards
that direction
Utilize inclusive behaviors

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