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Senior Manager, Manufacturing Sciences – Technology
Asahi KaseiSenior Manager leading manufacturing sciences strategy for commercial small molecule product in Cary, NC. Overseeing process validation and driving continuous improvement initiatives in high-volume manufacturing.
Posted 7/18/2026full-timeCary • North Carolina • 🇺🇸 United StatesSenior💰 $160,000 - $175,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in manufacturing science strategies, process validation, and continuous improvement initiatives within a high-volume commercial pharmaceutical environment. Proven ability to lead technical investigations, manage compliance, and mentor junior staff in a global manufacturing context.
Highest-signal resume keywords
Manufacturing Science StrategiesProcess ValidationContinuous Improvement InitiativesRegulatory SubmissionsTechnology Transfer
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process ValidationCPVLifecycle ManagementManufacturing InvestigationsChange ControlsDissolution TestingHigh-Volume Commercial ManufacturingFilm-Coated Dosage FormsModified-Release Dosage FormsSupplier Technical Performance Management
Soft Skills
MentoringCollaborationLeadership
Certifications & Qualifications
Bachelor's Degree in EngineeringPharmaceutical SciencesChemistryChemical EngineeringBiologyAdvanced Degree (MS, PhD, or MBA)
Industry Keywords
Pharmaceutical ManufacturingBiotechnologyRegulatory ComplianceQuality AssuranceQuality Control
About the role
Key responsibilities & impact- Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle
- Develop and execute manufacturing science strategies supporting a high-volume commercial program
- Provide advanced technical leadership supporting commercial manufacturing campaigns
- Drive continuous improvement initiatives focused on process capability, manufacturing reliability, product quality, and operational efficiency
- Lead execution of process validation and PPQ studies for new scales and suites
- Own CPV strategy, execution, and data trending across the commercial program
- Lead manufacturing investigations, deviations, CAPAs, and change controls
- Collaborate with Quality Assurance and Quality Control to ensure compliance and performance
- Manage supplier technical performance through governance meetings and business reviews
- Author technical content of regulatory submissions supporting global filings
Requirements
What you’ll need- Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or related scientific discipline
- Advanced degree (MS, PhD, or MBA) strongly preferred
- 10+ years of progressively responsible pharmaceutical or biotechnology manufacturing experience
- Demonstrated experience in technology transfer, process validation, CPV, lifecycle management, manufacturing investigations, and change controls
- Experience with film-coated, modified-release solid oral dosage forms and associated dissolution testing strongly preferred
- Experience supporting a high-volume commercial manufacturing program, including parallel scale-up or new suite qualification activities
- Experience supporting regulatory inspections and global regulatory submissions
- Demonstrated ability to mentor and develop junior technical staff within a global manufacturing organization and contract manufacturing network
Benefits
Comp & perks- health and insurance benefits
- training and development opportunities
- performance-based bonus eligibility