Summary
• This position will be located at Durham, NC site and will not have the ability to be located remotely.
Make a meaningful impact at the heart of biopharmaceutical manufacturing—where your expertise ensures life-changing therapies are produced safely, efficiently, and to the highest quality standards. As a Specialist in Manufacturing Technical Support, you’ll play a critical role partnering with production teams to optimize processes, solve complex challenges, and continuously improve performance. Your contributions will directly influence product quality, compliance, and innovation, helping deliver essential medicines to patients who need them most.
About the Role
Key Responsibilities:
- Provide real-time technical support to manufacturing teams to ensure safe, compliant, and on-time batch execution
- Collaborate with shift teams to resolve process issues and maintain uninterrupted production
- Revise and maintain master manufacturing documentation, including batch records, bills of material, and recipes
- Ensure critical process parameters remain within defined instructions and validated ranges
- Support technical assessments, root cause analysis, and quality risk assessments for process improvements
- Manage process changes through established change control procedures to ensure compliance
- Develop and update standard operating procedures and electronic manufacturing records
- Act as subject matter expert, providing insights on product and process trends and driving innovation
- Lead and author investigations, ensuring timely closure and effective CAPAs
- Support process monitoring, verification, and continuous improvement initiatives to enhance productivity and quality
Essential Requirements:
- Bachelor of Science degree in engineering or life sciences with relevant GMP manufacturing experience
- Minimum 5 years in biopharmaceutical GMP operations or 3 years in gene therapy manufacturing
- Experience authoring manufacturing documents and investigating complex deviations
- Strong knowledge of FDA regulations, cGMP systems, and pharmaceutical or biotech environments
- Experience supporting process troubleshooting, deviations, OOS, and OOE investigations
- Applied experience with Quality by Design (QbD), Six Sigma, and operational excellence tools
- Demonstrated experience with change control, CAPA management, and risk assessments
- Excellent written and verbal communication skills with strong technical writing capability
Desirable Requirements:
- Experience with upstream processing, cell expansion, or media preparation
- Exposure to gene therapy manufacturing
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $85,400 and $158,600 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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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
