Senior Manager, Manufacturing Sciences – Technology

Jobtailor; Cary (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor seeks an MS/PhD-level Manufacturing Science Leader to own the CPV strategy and drive process validation for a high-volume commercial small molecule program in Cary, NC. You will lead technology transfer, lifecycle management, and investigations across a global contract manufacturing network.

This senior role requires 10+ years in pharmaceutical manufacturing, strong mentoring, and a track record in regulatory submissions and continuous improvement.

Qualifications

• 10+ years in pharmaceutical or biotechnology manufacturing.
• Experience with technology transfer and CPV.
• Strong experience in process validation and change controls.
• Regulatory submissions experience.

Responsibilities

• Lead MS&T Product/Manufacturing Science strategies for high-volume programs.
• Drive process validation and PPQ studies for new scales and suites.
• Mentor staff within a global manufacturing network.
• Collaborate with QA/QC to ensure compliance and performance.

Skills

Manufacturing Science Strategies

Process Validation

Continuous Improvement

Regulatory Submissions

Technology Transfer

Education

Bachelor's degree in Engineering

Advanced degree (MS, PhD, or MBA)

Job description

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

Requirements

• 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

Core Competencies

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

Hard Skills

• 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

Soft Skills

• Mentoring
• Collaboration
• Leadership

Certifications & Qualifications

• Bachelor's Degree in Engineering
• Pharmaceutical Sciences
• Chemistry
• Chemical Engineering
• Biology
• Advanced Degree (MS, PhD, or MBA)

Industry Keywords

• Pharmaceutical Manufacturing
• Biotechnology
• Regulatory Compliance
• Quality Assurance
• Quality Control