Specialist, Operational Excellence

Durham, NC, US
Jun 03, 2021
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Specialist, Operational Excellence, supports all site functions at the NC site. This role reports to the Site Operation Manager and serves as the site lead for all operational excellence initiatives at the site as well as collaboration with NTO.

  • Identifies, develops and implements process robustness improvements through lean principals.
  • Leads lean and six sigma training needs for the site.
  • Develops and maintains the operational excellence portfolio of projects/activities for the site.
  • Helps establish key metrics, tracking results, and supports the sites ability to perform and deliver to plan.
  • Implements value stream mapping, visual control boards and provides ongoing support to each of the sitewide functions.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines.
  • Management of multiple projects and timelines concurrently.
  • Works on the manufacturing, warehouse and quality lab shop floors for data gathering and observing of processes.
  • Supports the Project Management team and participates and assists with the Hoshin Kanri process.
  • Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, engineering and the supply chain functions at both production sites.
  • Maintains quality standards to meet GMP requirements, CFR's and internal company policies with respect to operations.
  • Other related duties as assigned.

  • B.S. degree in Engineering or the life sciences and 5 years of work experience in lean biopharmaceutical based GMP manufacturing operations.
  • In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.
  • Applied knowledge of value stream mapping, tier structures, six-sigma, lean and operational excellence tools in creating efficient and high-quality processes and end products.
  • Ability to facilitate problem solving, work with the shop floor and collaborate with multiple functions for process improvement initiatives.
  • Excellent project management, oral and written communication skills.
  • Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
  • Statistical analysis capabilities.
  • Six-sigma green belt or black belt preferred.
  • Travel as required to other internal sites, vendors, and CMOs as required (5-15%).

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.