Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Director, Commercial Manufacturing Validation

DirectorDirectorFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

94 days ago

Salary

$173.2K - $216.5K / year

Postgraduate Degree10 yrs expEnglish

Job Description

• Contributing to validation strategies, programs, and continuous improvement initiatives • Maintain the policies and procedures for a compliant Lifecycle Validation model • Establish and maintain Validation Master Plans for all SMPA programs/projects • Lead/support technical transfers activities from a validation and compliance perspective • Partner on a global level in cross functional teams with internal resources and external CMOs • Accountable for ensuring compliant validation of equipment and utilities qualification/validation • Plan, Design and execute major NDA/MAA enabling projects • Lead author for applicable sections in regulatory submissions • Participate in all validation activities pertaining to commercial products

Job Requirements

  • Minimum 10 – 15 years (w/o Masters) or 8 – 12 years (with Master’s) of relevant experience in biotech or pharmaceutical industry
  • Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products)
  • Familiarity with EMA and FDA validation requirements, including Lifecycle Model
  • Lean Six Sigma training/certification is preferred

Benefits

  • merit-based salary increases
  • short incentive plan participation
  • eligibility for 401(k) plan
  • medical, dental, vision, life and disability insurances
  • flexible paid time off
  • 11 paid holidays
  • additional time off during the last week of December
  • 80 hours of paid sick time upon hire and each year thereafter

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