Project Director, Drug Substance

Band

Level 6

 

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.

 

Job Description

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.

 

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration a