Project Director, Drug Substance Job at Universal Hierarchy Node, Durham, NC

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  • Universal Hierarchy Node
  • Durham, NC

Job Description

Summary

#LI-Onsite

Location: Durham, NC

As Project Director, Drug Substance, you’ll drive operational excellence and shape the future of large molecule manufacturing in Durham, NC. This is your opportunity to make a lasting mark—leveraging your deep operations experience to guide a talented team, ensure compliance, and deliver results that matter. Your expertise in engineering and project management will be essential as you build, mentor, and inspire cross-functional teams, manage complex projects from design through commercialization, and champion a culture of collaboration and innovation. Join us to help deliver life-changing medicines while advancing your career in a dynamic, growth-focused environment.

About the Role

Key Responsibilities:

  • Lead the project team to achieve operational, quality, and compliance objectives within scope, budget, and timeline.
  • Develop and manage comprehensive project plans that are strategically aligned with deliverables, business targets, and the priorities of senior stakeholders and cross-functional leaders.
  • Establish and guide a senior project team, serving as the main contact for project governance and escalation.
  • Proactively identify risks and create effective contingency plans to ensure project success.
  • Build and maintain a capable organization, ensuring resources are available and transitioned smoothly to commercial operations.
  • Ensure readiness for regulatory inspections and audits in partnership with the Quality organization.
  • Oversee project budget, schedule, and quality requirements, ensuring compliance with procurement and accounting standards.
  • Work seamlessly with Commercial Operations and large molecule Drug Substance sites to ensure efficient product launches from the new facility, seamless technology transfer, and smooth integration into manufacturing operations.
  • Collaborates closely with manufacturing, SC, MS&T, Engineering, Quality, P&O, and Finance to ensure compliance and strong alignment.
  • Coach, mentor, and lead the facility team with a clear structure and accountability to enable fast decisions and efficient execution of business strategy.

Essential Requirements:

  • Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Engineering, or related field; MBA preferred.
  • Minimum 10 years’ experience in senior Manufacturing, Project Management or Engineering roles in pharma or life sciences.
  • Experience with large molecule drug substance.
  • Proven leadership and change management skills, with a track record of building and managing high-performing teams.
  • Prior success in large-scale technology transfer or new facility start-up within the pharmaceutical or life sciences industry.
  • Demonstrated ability to work effectively in a global, networked environment and across diverse cultures.
  • Strong operations expertise, with experience leading site organizations from capital project design through commercialization.
  • Excellent communication and stakeholder management skills at senior levels.

Desirable Requirements:

  • Experience with mammalian drug substance manufacturing highly preferred.
  • Previous experience across multiple functions - Manufacturing Operations, Project Management and Engineering.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $160,300 and $297,700 per year.

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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

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 & 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.

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