Manufacturing Specialist, Deviation/CAPA

Location
Durham, NC, US
Posted
Sep 01, 2020
Ref
5477
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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 Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

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 ensure 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.

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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