Sr. Manager, Manufacturing Operational Readiness / Drug Substance

Job Description Summary

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.

 

Job Description

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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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Salary Range

$108,500.00 - $201,500.00

 

Skills Desired

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