Specialist, Manufacturing Projects

Location
Durham, NC, US
Posted
May 25, 2021
Ref
6062
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.

The Specialist, Manufacturing Projects, is responsible for providing project support for new product introductions and site change controls.

Responsibilities

\u2022 Implementation and delivery of new Commercial and Clinical products into the facility.\u2022 Owns change controls which supports site-wide initiatives alongside manufacturing processes in upstream, downstream, fill/finish, and/or manufacturing support groups.\u2022 Owns and manages technology transfer projects, to include new product change controls for the introduction of clinical and commercial production at the site.\u2022 Manages projects to implement significant changes to existing manufacturing processes.\u2022 Owns and manages site-wide change controls associated with the implementation of global systems associated with production, supply chain and quality systems.\u2022 Supports the PMO group for any technology transfer activities.\u2022 Maintains quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.\u2022 Identifies, develops and implements process robustness improvements through lean principals.\u2022 Supports Deviation/CAPA team.\u2022 Support internal and external audits for group owned change controls.\u2022 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 operation
  • 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.

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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