Director, Commercial Manufacturing Validation
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $173,200 - $216,500 per year
Job Level
Lead
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
validation strategiesLifecycle Validation modelValidation Master Planstechnical transfersequipment qualificationutilities validationNDA projectsMAA projectsregulatory submissionsvalidation activities
Soft skills
cross functional collaborationglobal partnershipleadershipaccountabilitycommunication
Certifications
Lean Six Sigma