Job Description Summary
Step into a high-impact role where your expertise will directly shape the delivery of life-saving therapies. As a key member of Manufacturing Science and Technology, you’ll lead process improvements and drive innovation in sterile drug product manufacturing, partnering cross-functionally to ensure quality, efficiency, and reliability. This is your opportunity to solve complex challenges, influence production outcomes, and play a critical role in bringing medicines to patients.
Job Description
Location:
- This position will be located in Durham, NC and will be an onsite role.
- Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 in collaboration 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 projects, including remediation and process enhancement initiatives
- Support technology transfer to ensure seamless transition into compliant GMP manufacturing
- Collaborate with Quality to maintain a compliant and inspection-ready production environment
Essential Requirements:
- Bachelor of Science degree with 6 years, Master of Science with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience
- Strong experience supporting GMP drug product manufacturing environments, including 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 with strong technical writing capability
- Demonstrated 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 contribute to continuous improvement initiatives
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $114,100 to $211,900 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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Salary Range
$114,100.00 - $211,900.00
Skills Desired
Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology Transfer
