Sr. Engineer, MS&T – Aseptic Drug Product

Location: Durham, NC – onsite role; relocation support is not available.

About the Role

Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As a key member of the Manufacturing Science and Technology team, you will provide technical leadership to advance aseptic manufacturing operations, drive process performance, and support the successful introduction of new products and technologies. Working closely with Manufacturing, Quality, Engineering, and global partners, you will help solve complex challenges, lead continuous improvement initiatives, and ensure a reliable supply of high-quality products for patients.

Responsibilities

• Lead Continued Process Verification (CPV) activities by analyzing process data, identifying trends, and driving process performance improvements.
• Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
• Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
• Monitor and trend Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) to ensure consistent product quality and process control.
• Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
• Support the introduction of new equipment, systems, and manufacturing processes through startup and implementation activities.
• Author and support process change documentation while collaborating with Engineering, Manufacturing, and Validation teams.
• Provide technical expertise for remediation efforts, project deliverables, technical assessments, and process reports.
• Collaborate with Development and site partners to execute Tech Transfer activities and ensure successful product commercialization.
• Drive Operational Excellence (OPEX) initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.

Requirements

• Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; or
• Master’s degree with 4+ years of experience; or
• Doctorate degree with 2+ years of experience.
• Proven experience supporting GMP biopharmaceutical manufacturing operations within a regulated environment.
• Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
• Experience supporting Tech Transfer, process validation, lifecycle management, or manufacturing process improvements.
• Working knowledge of global GMP regulations, validation requirements, and quality compliance expectations.
• Strong analytical skills with the ability to interpret process data, identify trends, and drive data-based decisions.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Demonstrated ability to lead technical initiatives and contribute effectively within cross-functional teams.

Pay

The salary for this position is expected to range between $114,100 and $211,900 annually. The final salary offered is determined based on factors such as relevant skills and experience. Upon joining, salary will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Benefits

• Performance-based cash incentive and eligibility for annual equity awards.
• Comprehensive benefits package including health, life, and disability benefits.
• 401(k) with company contribution and match.
• Generous time off package including vacation, personal days, holidays, and other leaves.