Manufacturing Specialist, Deviation/CAPA

Location
Durham, NC, US
Posted
Jul 18, 2021
Ref
6044
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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.Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Manufacturing Specialist, Deviation/CAPA, is responsible for providing support to the engineering, validation, MSAT, maintenance, QC and QA groups at a site.

Responsibilities
  • Investigates complex deviations and supports the applicable CAPAs discovered in the upstream, downstream, fill/finish, or manufacturing support groups.
  • Ensures programs and manufacturing are in a state of control and all non-conformances are managed within the given timelines.
  • Provides complex deviation/CAPA support for the manufacturing process owners/groups.
  • Participates in the site deviation/CAPA forum and ensures collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions are aligned with investigation progress and results.
  • Serves as a lead investigator for complex deviations, escalating issues as required.
  • Serves as a lead investigator/mentor for non-complex deviations owned by other groups.
  • Ensures all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of corrective and preventive action plans. Assist with implementation and supporting on-going continuous improvements.
  • Identifies, develops and implements process robustness improvements through lean principals.
  • Supports internal and external audits for complex deviations.
  • Supports the PMO group for any technology transfer activities.
  • Supports site change controls as needed.
  • Maintains quality standards to meet GMP requirements, CFRs and internal company policies with respect to the Deviation/CAPA process.
  • Other related job duties as assigned.

Qualifications
  • B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools.
  • In-depth knowledge of FDA regulations and GMP systems and experience interacting with various regulatory agencies 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 (~10%).


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.

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