Specialist, Manufacturing Technical Support

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 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.Key Responsibilities:Provide real-time technical support to manufacturing teams to ensure safe, compliant, and on-time batch executionCollaborate with shift teams to resolve process issues and maintain uninterrupted productionRevise and maintain master manufacturing documentation, including batch records, bills of material, and recipesEnsure critical process parameters remain within defined instructions and validated rangesSupport technical assessments, root cause analysis, and quality risk assessments for process improvementsManage process changes through established change control procedures to ensure complianceDevelop and update standard operating procedures and electronic manufacturing recordsAct as subject matter expert, providing insights on product and process trends and driving innovationLead and author investigations, ensuring timely closure and effective CAPAsSupport process monitoring, verification, and continuous improvement initiatives to enhance productivity and qualityEssential Requirements:Bachelor of Science degree in engineering or life sciences with relevant GMP manufacturing experienceMinimum 5 years in biopharmaceutical GMP operations or 3 years in gene therapy manufacturingExperience authoring manufacturing documents and investigating complex deviationsStrong knowledge of FDA regulations, cGMP systems, and pharmaceutical or biotech environmentsExperience supporting process troubleshooting, deviations, OOS, and OOE investigationsApplied experience with Quality by Design (QbD), Six Sigma, and operational excellence toolsDemonstrated experience with change control, CAPA management, and risk assessmentsExcellent written and verbal communication skills with strong technical writing capabilityDesirable Requirements:Experience with upstream processing, cell expansion, or media preparationExposure to gene therapy manufacturingNovartis Compensation and Benefit Summary:The salary for this position is expected to range between $85,400 and $158,600 annuallyThe 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