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Job Description Summary

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.

Shift:

• This role will work on a rotating 2-2-3 night shift (5:45 pm – 6:15 am)
• Candidates must be flexible, as schedules may be adjusted periodically to support training, business needs, and operational requirements.

Key Responsibilities

• Lead daily manufacturing operations to ensure safe, compliant, and efficient production of clinical and commercial materials.
• Coordinate shift activities, assign resources, and serve as the primary point of contact during operational events.
• Drive adherence to cGMP requirements, safety standards, and quality expectations across all manufacturing activities.
• Lead investigations, author deviations, non-conformances, and CAPAs, and ensure timely resolution of quality issues.
• Partner closely with Quality and cross-functional teams to support compliant and effective manufacturing operations.
• Ensure batch records, SOPs, and manufacturing documentation are accurate, complete, and inspection-ready.
• Identify, implement, and sustain continuous improvement initiatives that enhance performance, quality, and efficiency.
• Monitor manufacturing processes and provide technical oversight to support consistent operational execution.
• Mentor, coach, and develop team members while fostering a collaborative, high-performing culture.
• Communicate shift performance, key updates, and operational priorities to stakeholders through clear and timely reporting.

Essential Requirements

• Bachelor's degree in Biology, Chemistry, Biotechnology, or a related field with 5+ years of cGMP manufacturing experience; OR 3+ years manufacturing Novartis Gene Therapies products; OR 7+ years of relevant cGMP manufacturing experience in lieu of a degree.
• Hands-on experience in biologics, pharmaceutical, vaccine, or gene therapy manufacturing, including cell culture, recovery, purification, bulk formulation, or fill-finish operations.
• Strong knowledge of FDA regulations, GMP requirements, and quality management systems within a regulated manufacturing environment.
• Experience leading investigations, resolving deviations and non-conformances, and authoring CAPAs and related documentation.
• Excellent verbal and written communication skills, including technical writing and cross-functional collaboration.
• Demonstrated project management capabilities with experience in planning, prioritizing, and executing operational objectives.
• Proven ability to lead, coach, and develop teams in a fast-paced manufacturing environment.
• Ability to lift 35 pounds or more and travel up to 10% as required.

Desirable Requirements

• Experience supporting Drug Product manufacturing operations, including fill-finish processes, is highly preferred.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $41.06 and $76.25 per hour

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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Salary Range

Skills Desired