RA Capital

Band

Level 6

Job Description Summary

Location: Durham, NC

Step into a pivotal leadership role where your expertise will directly shape the future of advanced manufacturing. As Site MS&T Head, you will serve as a key member of the Campus Leadership Team, leading the scientific and technical backbone of our Durham site across Gene Therapy, Aseptic Drug Product (ADP), Large Molecules (LMO), and all clinical operations. You will drive innovation, ensure product quality, and enable the successful delivery of cutting-edge therapies to patients. This is a unique opportunity to influence site strategy, build high-performing teams, and champion technical excellence across the full product lifecycle in a highly visible, impact-driven environment.

Job Description

Key Responsibilities

• Develop and execute MS&T strategy aligned with site and platform objectives, including process scaling and technical transfers
• Drive financial, operational, and resource performance across safety, quality, supply, and cost targets
• Ensure robust product stewardship for all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of the commercial lifecycle.
• Ensure oversight of technical changes and lead end-to-end change control management related to relevant technical issues, working cross-functionally as needed.
• Act as the interface for the site with the relevant Health Authorities for technical issues.
• Lead aseptic validation and partner with Engineering on the site Validation Master Plan, ensuring all processes and products remain validated and in a continuous state of control throughout the lifecycle
• Accountable for technical transfers into, within, and out of the site
• Partner with technical research and development organizations teams to ensure successful scale-up and commercialization of new products
• Drive process optimization, innovation, and adoption of new technologies, technologies, equipment, AI and robotics.
• Collaborate cross-functionally to ensure that Technical Life Cycle Management (TLCM) projects are identified, prioritized and delivered with excellence.
• Build organizational capability through technical training, knowledge management, and succession planning

Essential Requirements

• MSc. in Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.D. desirable.
• Minimum 15 years’ experience in manufacturing. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
• Proven experience driving quality and compliance in an organization.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Fundamental understanding of standard pharmaceutical analytical testing.

Desirable Requirements

• Deep expertise in gene therapy manufacturing, including drug product filling experience.
• Experience leading large, complex technical organizations in advanced therapy or aseptic manufacturing environments

The salary for this position is expected to range between $ 168,000 and $312,000 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.

To learn more about the culture, rewards and benefits we offer our people click here.

#LI-Onsite

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 and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$168,000.00 - $312,000.00

Skills Desired

Data Analytics and Digital, Finance Acumen, GDP Knowledge, gmp knowledge, HSE Knowledge, Leadership, Manufacturing Process Science, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Strategic Thinking, Technical Leadership, Technology Transfer