Sr. Manager, Manufacturing – Operational Readiness / Drug Substance

Location:

• This position will be located in Durham, NC and will be an onsite role.

Key Responsibilities:

• Act as manufacturing deputy to the Project Director, supporting operational readiness and design integration.
• Lead and integrate manufacturing requirements into facility design, including personnel, material, and waste flows.
• Drive operational readiness planning across organization setup, process readiness, and start-up activities.
• Lead manufacturing readiness execution with strong focus on timelines, quality, and delivery outcomes.
• Own manufacturing change controls and conduct impact and risk assessments with quality and safety partners.
• Ensure facility design supports safe, compliant, and efficient large-scale drug substance manufacturing operations.
• Develop staffing models, training strategies, and onboarding plans for manufacturing teams.
• Manage manufacturing readiness budgets, forecasts, and cost tracking throughout the project lifecycle.
• Partner cross-functionally with engineering, validation, supply chain, and quality to ensure manufacturing integration.
• Identify and resolve complex operational challenges independently, driving decisions with minimal oversight.

Essential Requirements:

• Bachelor of Science degree in engineering, biological sciences, or a related technical field.
• Minimum of 8 years of experience in GMP biopharmaceutical manufacturing.
• Proven experience in large-scale drug substance manufacturing using highly automated systems (e.g. stainless steel systems).
• Strong knowledge of GMP quality systems, change control processes, and risk management principles.
• Experience supporting facility start-up, capital projects, or operational readiness for new manufacturing sites.
• Demonstrated ability to work independently and deliver results with minimal supervision.
• Strong problem-solving skills with ability to manage complex challenges and drive effective decisions.
• Excellent communication skills with ability to engage technical teams and senior stakeholders.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $108,500 and $201,500 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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