Job Description Summary
Are you passionate about advancing sterile manufacturing processes that help deliver life-changing therapies to patients? As an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product, you will play a critical role in supporting and improving aseptic fill-finish manufacturing operations, partnering across technical, quality, and manufacturing teams to ensure reliable product supply, operational excellence, and the highest standards of quality. This is an opportunity to apply your scientific and engineering expertise in a collaborative environment where your contributions directly impact patients while helping shape the future of advanced manufacturing at Novartis.
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:
- Monitor and analyze process performance data to support continued process verification and product quality.
- Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
- Trend critical quality attributes and process parameters to identify risks and drive improvements.
- Support technology transfer activities for new products and processes into commercial manufacturing.
- Identify and implement continuous improvement opportunities that enhance operational performance.
- Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
- Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
- Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
- Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
- Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.
Essential Requirements:
- Bachelor27s degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 4+ years of biopharmaceutical GMP manufacturing experience, including aseptic fill-finish operations; 3+ years of direct Novartis Gene Therapies experience with aseptic fill-finish operations; or a Master of Science degree in a related technical field with 2+ years of relevant aseptic fill-finish or engineering experience.
- Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles.
- Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
- Strong technical writing skills with the ability to develop accurate and compliant documentation.
- Proven ability to collaborate effectively across cross-functional teams and communicate with diverse stakeholders.
- Ability to travel up to 10% as required.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $89,600 and $166,400 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.
#LI-Onsite
Salary Range
$89,600.00 - $166,400.00
Skills Desired
Continual Improvement Process, Manufacturing Production, Operational Excellence, Process Control, Regulatory Compliance
