Specialist, Manufacturing - Fill Finish

Durham, NC, US
Apr 07, 2021
Bio NC
Required Education
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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site.

  • Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support).
  • Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites.
  • Serve as a manufacturing document owner for certain production process steps.
  • Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs.
  • Identify, develop and implement process robustness improvements through lean principals.
  • Lead process specific training for the direct manufacturing group.
  • Support internal and external audits for manufacturing process steps.
  • Support the PMO group for any technology transfer activities.
  • Own manufacturing process related change controls.
  • Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.
  • Responsible for providing manufacturing SME support on capital related projects.

  • Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations.
  • Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations.
  • 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 Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Travel as required to other internal sites, vendors, and CMOs as required (~20%).

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

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.