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Job Description

Lead technical support for GMP manufacturing operations with a focus on compliance, quality, and operational reliability.

Responsibilities

  • Lead and develop the Manufacturing Technical Support team supporting GMP production operations
  • Provide technical oversight and troubleshooting to resolve complex manufacturing and process challenges
  • Drive continuous improvement initiatives to strengthen safety, quality, compliance, and operational efficiency
  • Partner with Manufacturing, Quality, Engineering, and other functions to meet production objectives
  • Ensure timely investigation of deviations and effective CAPA activities
  • Support change control activities and assess manufacturing impact of process or equipment changes
  • Monitor process performance data to identify opportunities for reliability and productivity improvements
  • Oversee creation, review, and approval of GMP documentation, including SOPs and manufacturing records
  • Build team capability through coaching, training, performance management, and employee development
  • Maintain inspection readiness and ensure compliance with FDA, GMP, and company quality standards

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a related scientific discipline
  • Minimum 7 years of experience in pharmaceutical, biopharmaceutical, biotechnology, or chemical manufacturing environments
  • Demonstrated leadership experience managing technical teams and developing high-performing employees
  • Strong knowledge of GMP regulations and FDA requirements within a manufacturing setting
  • Experience leading deviation investigations, root cause analysis, and CAPA implementation
  • Proven ability to support manufacturing operations and resolve complex technical challenges
  • Experience collaborating across Quality, Manufacturing, Engineering, and Supply Chain functions
  • Strong communication, problem-solving, and organizational skills in a fast-paced regulated environment

Benefits

  • Performance-based cash incentive
  • Eligibility to be considered for annual equity awards (depending on the level of the role)
  • Comprehensive benefits package including health, life and disability benefits
  • 401(k) with company contribution and match
  • Variety of other benefits
  • Generous time off package including vacation, personal days, holidays, and other leaves

Compensation

  • Estimated salary range: $108,500 to $201,500 per year
  • Final salary depends on factors including relevant skills and experience; reviewed periodically after joining
  • Salary range may be updated based on company and market factors

Job Details

  • Division: Operations
  • Business Unit: Production / Manufacturing
  • Functional Area: Technical Operations
  • Job Type: Full time
  • Employment Type: Regular
  • Shift Work: No
  • Schedule/Location: Durham, NC (onsite)
  • Country: USA
  • State: North Carolina
  • Site: Durham
  • Company/Legal Entity: U473 (FCRS = US473) Novartis Innovative Technologies Inc
  • Accessibility: Reasonable accommodations are available. Email [email protected] or call +1(877)395-2339 and include the job requisition number.

Relocation: Novartis is unable to offer relocation support for this role. Please apply only if Durham, NC is accessible for you.

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