Senior Manager, Manufacturing Sciences – Technology
Job in
Cary, Wake County, North Carolina, 27518, USA
Listed on 2026-07-23
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-23
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering -
Pharmaceutical
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Responsibilities
- 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
- 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
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 Strategies
- Process Validation
- Continuous Improvement Initiatives
- Regulatory Submissions
- Technology Transfer
- Process Validation
- CPV
- Lifecycle Management
- Manufacturing Investigations
- Change Controls
- Dissolution Testing
- High-Volume Commercial Manufacturing
- Film-Coated Dosage Forms
- Modified-Release Dosage Forms
- Supplier Technical Performance Management
- Mentoring
- Collaboration
- Leadership
- Bachelor's Degree in Engineering
- Pharmaceutical Sciences
- Chemistry
- Chemical Engineering
- Biology
- Advanced Degree (MS, PhD, or MBA)
- Pharmaceutical Manufacturing
- Biotechnology
- Regulatory Compliance
- Quality Assurance
- Quality Control
Position Requirements
10+ Years
work experience
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