Sr. Engineer, MS&T - Aseptic Drug Product

NCBioImpact; Durham (NC); On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis in Durham, NC seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead technical initiatives across aseptic manufacturing and tech transfer.

You will partner with Manufacturing, Quality, Engineering, and global teams to drive process performance, support new products, and ensure reliable, high-quality aseptic products for patients. You will apply data-driven approaches to CQAs/CPPs, lead investigations, and advance continuous improvement while ensuring

Qualifications

• Bachelor’s degree with 6+ years biopharmaceutical manufacturing experience; Master’s 4+ years; Doctorate 2+ years.
• GMP biopharmaceutical manufacturing operations experience.
• Hands-on aseptic fill-finish operations and sterile drug product manufacturing.
• Experience with Tech Transfer, process validation, lifecycle management.
• Knowledge of global GMP regulations and quality compliance expectations.

Responsibilities

• Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
• Serve as MS&T technical lead for manufacturing investigations and root cause analysis.
• Support production schedules, commercial supply, and GMP compliance.
• Monitor and trend CQAs and CPPs to ensure product quality and process control.
• Identify and implement process improvements to enhance reliability, efficiency, and performance.
• Support introduction of new equipment, systems, and processes through startup activities.
• Author/update process change documentation with Engineering, Manufacturing, and Validation teams.
• Provide technical expertise for remediation efforts, project deliverables, and technical assessments.
• Collaborate with Development and site partners to execute Tech Transfer and product commercialization.
• Drive OPEX initiatives and foster continuous improvement and manufacturing excellence.

Skills

Data analytics

Change controls

Process validation

Technical leadership

Team collaboration

GMP compliance

Statistical analysis

Education

Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related field

Master’s degree (4+ years experience)

Doctorate (2+ years experience)

Job description

Band

Level 4

Job Description Summary

Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will play a critical role in advancing aseptic manufacturing operations by providing technical leadership, driving process performance, and supporting 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. This is an exciting opportunity to make a meaningful impact in a collaborative environment that values innovation, scientific excellence, and operational excellence.

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 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 CQAs and 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 OPEX initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.

Essential Requirements

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; 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.

Novartis Compensation and Benefit Summary

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 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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EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e‑mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Applied Statistics, Change Controls, Cleaning Validations, Data Analytics, Emotional Resilience, Good Documentation Practices, Health, Safety, and Environment (HSE) Policy, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Process Validation, Quality Compliance, Regulatory Compliance, Risk Management, Technical Leadership, Technology Transfer