Senior Engineer, MS&T
Novartis
9 hours ago
On-site
Durham, NC
Operations
Key Responsibilities:
- Lead process investigations to resolve manufacturing issues and drive continuous improvements
- Analyze process verification data to identify trends and ensure consistent product quality
- Partner with manufacturing to meet production schedules and maintain reliable drug supply
- Monitor critical quality attributes and process parameters to control variability and drift
- Implement process improvements with operations and engineering teams
- Support startup and qualification of new equipment, systems, and manufacturing processes
- Document and manage updates to manufacturing processes in compliance with quality standards
- Provide technical expertise for remediation and process enhancement initiatives
- Support technology transfer to transition into compliant GMP manufacturing
- Collaborate with Quality to maintain a compliant and inspection-ready production environment
Essential Requirements:
- BS with 6 years, MS with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience
- Strong experience in GMP drug product manufacturing (aseptic processing and fill/finish operations)
- Proven ability to analyze data and apply scientific principles to solve complex process issues
- Excellent written and verbal communication skills and strong technical writing
- Ability to collaborate effectively across cross-functional teams
- Familiarity with global regulatory requirements for drug products, validation, and qualification
- Ability to manage multiple priorities and drive continuous improvement
Compensation & Benefits (as stated):
- Salary expected: $114,100–$211,900 annually; performance-based cash incentive; possible annual equity awards
- US-based employees: comprehensive benefits package (health, life, disability, 401(k) with match) and time off (vacation, personal days, holidays, other leaves)
- Lead process investigations to resolve manufacturing issues and drive continuous improvements
- Analyze process verification data to identify trends and ensure consistent product quality
- Partner with manufacturing to meet production schedules and maintain reliable drug supply
- Monitor critical quality attributes and process parameters to control variability and drift
- Implement process improvements with operations and engineering teams
- Support startup and qualification of new equipment, systems, and manufacturing processes
- Document and manage updates to manufacturing processes in compliance with quality standards
- Provide technical expertise for remediation and process enhancement initiatives
- Support technology transfer to transition into compliant GMP manufacturing
- Collaborate with Quality to maintain a compliant and inspection-ready production environment
Essential Requirements:
- BS with 6 years, MS with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience
- Strong experience in GMP drug product manufacturing (aseptic processing and fill/finish operations)
- Proven ability to analyze data and apply scientific principles to solve complex process issues
- Excellent written and verbal communication skills and strong technical writing
- Ability to collaborate effectively across cross-functional teams
- Familiarity with global regulatory requirements for drug products, validation, and qualification
- Ability to manage multiple priorities and drive continuous improvement
Compensation & Benefits (as stated):
- Salary expected: $114,100–$211,900 annually; performance-based cash incentive; possible annual equity awards
- US-based employees: comprehensive benefits package (health, life, disability, 401(k) with match) and time off (vacation, personal days, holidays, other leaves)