Manufacturing Project Specialist

Location
Durham, NC, US
Posted
Sep 01, 2020
Ref
5464
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.

This position in Manufacturing Support is responsible for providing project support for New Product Introductions and Site Change Controls.

Responsibilities
  • The Project Specialist will be responsible for the implementation and delivery of new Commercial and Clinical products into the facility.
  • Own change controls which support sitewide initiatives alongside manufacturing processes in upstream, downstream, fill/finish, and/or manufacturing support groups.
  • Own and manage technology transfer projects, to include new product change controls for the introduction of clinical and commercial production at the site.
  • Manage projects to implement significant changes to existing manufacturing processes.
  • Own and manage site-wide change controls associated with the implementation of global systems associated with production, supply chain and quality systems.
  • Support the PMO group for any technology transfer activities.
  • Maintain quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.
  • Identify, develop and implement process robustness improvements through lean principals.
  • Support Deviation/CAPA team.
  • Support internal and external audits for group owned change controls.
  • Other related 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.
  • Experience in technology transfer of biotechnology candidate clinical products and/or technology transfer of commercial products from site to site.
  • 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 (~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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