Specialist, Manufacturing Technical Support

Band Level 3 Job Description Summary Location: 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 manufacturingwhere your expertise ensures life-changing therapies are produced safely, efficiently, and to the highest quality standards. As a Specialist in Manufacturing Technical Support, youll 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. Job Description 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. #LI-Onsite 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 tas.nacomms@novartis.com 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. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $85,400.00 - $158,600.00 Skills Desired Data Analytics, digital skills, General Hse Knowledge , gmp knowledge, process excellence, Resilience Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing peoples lives. Novartis is aware of employment scams which make false use of our company name or leaders names or recruiters names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. 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