REQ-10052715
6月 02, 2025
USA

摘要

#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.

About the Role

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.

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? https://www.novartis.com/about/strategy/people-and-culture

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: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Operations
Innovative Medicines
USA
North Carolina
Durham
Technical Operations
Full time
Regular
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10052715

Project Director, Drug Substance

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