Sr. Manager, Manufacturing – Operational Readiness / Drug Substance

Novartis • Durham, NC

8d • Onsite

About The Position

Play a critical role at the forefront of building a next-generation biologics manufacturing facility. As Senior Manager, Manufacturing – Operational Readiness, you will act as the manufacturing deputy to the Project Director, ensuring manufacturing requirements are fully integrated into design, readiness planning, and start-up execution. This is a unique opportunity to operate with a high degree of independence—driving decisions, resolving complex challenges, and shaping how manufacturing capabilities come to life in a large-scale drug substance facility that will ultimately deliver life-changing therapies to patients.

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.

Nice To Haves

• Data Analytics
• digital skills
• General Hse Knowledge
• gmp knowledge
• process excellence
• Resilience

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.

Benefits

• performance-based cash incentive
• eligibility to be considered for annual equity awards
• health, life and disability benefits
• a 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Manager