Project Director, Drug Substance

Job Description Summary

#LI-Onsite

Location: This role is located on-site in Durham, NC.

The Project Director, Drug Substance within Large Molecule, is responsible for regulatory compliance, strategic leadership, and operational management. This position involves managing technical complexity, process scale-up, regulatory requirements, and cross-functional coordination. The role includes overseeing a significant capital investment and start-up facility. By applying scientific expertise alongside leadership and problem-solving skills, the Project Director ensures the quality production of drug substances for large-molecule therapies.

 

Job Description

Role responsibilities:

• Leads the senior project team and serves as the primary point of contact for project governance. Accountable for project team performance and developing a comprehensive project plan.
• Aligns project strategy and deliverables with key business stakeholders.
• Responsible for budget management, unit cost control, and financial KPIs.
• Manages the project budget, schedule, and quality requirements.
• Conducts risk management and develops contingency plans.
• Leads capital project execution from design through commercialization.
• Instrumental in leading Tech Transfer and scale-up activities
• Develops a robust organizational structure and resource strategy to smoothly transition from project phase to commercial operations. Provides coaching and mentoring, promoting an inclusive and high-performance culture.
• Ensures regulatory compliance readiness for inspections and audits.
• Maintains acceptable standards of product/process quality, HSE, and Security.

Role Requirements:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or Engineering; Advanced degree preferred.
• Minimum 10 years of experience in senior Manufacturing, Technical Operations and Supply Chain Management roles in the pharmaceutical or life sciences industry.
• Demonstrated experience in leadership and change management, along with prior success in developing and overseeing multi-level organizations.
• Possesses the ability to work in a global, networked environment.
• Demonstrated expertise in developing and managing site organizations, spanning from large-scale capital project design and construction to commercialization phases.

Desirable Requirements:

• Experience in drug substance within large molecule preferred.

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $160,300 to $297,700/yearly. 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. To learn more about the culture, rewards and benefits we offer our people click here.

 

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 us.reasonableaccommodations@novartis.com 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

$160,300.00 - $297,700.00

 

Skills Desired

Assembly Language, Biotechnology, Change Management, Chemistry, Continual Improvement Process, Cost Reduction, Finance, General Hse Knowledge     , Incentive Program, Installations (Computer Programs), Knowledge Of Gmp, Leadership, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Operational Excellence, Productivity, Purchase, Six Sigma