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Packaging Engineer Iii Jobs

Company

Novartis Gene Therapies

Address Durham, NC, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-09-20
Posted at 10 months ago
Job Description
Imagine… 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.
The Packaging Engineer III, is responsible for evaluation, design, and optimization activities for commercial and clinical gene therapy product packaging.
Responsibilities
  • Recommends and qualifies packaging and labeling materials, creating material specifications, performing packaging stability testing and evaluation.
  • Technical assessments and validation of temperature controlled (Cold Chain) shipping systems.
  • Other related duties as assigned.
  • Serve as a key resource in the management and oversite of new market launches.
  • Designs and executes testing performed internally, oversees testing at external labs.
  • Leads and owns or contribute to GMP Change Controls.
  • Designs, executes, and documents qualifications/validations.
  • Supports and leads various aspects of global launch projects.
  • Provides guidance to cross functional business partners related to product packaging.
  • Leads cross-functional teams to launch gene therapy products in markets around the globe.
  • Leads packaging projects including, but not limited to, optimization and problem solving for current packaging and new developments for pipeline products.
  • Proactively coordinates, communicates, and provides essential Packaging and Labeling Development project information, activities, and technical assistance to Development, Clinical, Planning, Manufacturing, Quality Assurance, and Purchasing in a timely manner without becoming the critical path.
  • Designs, develops, and qualifies secondary and tertiary packaging, and shipping systems.
Qualifications
  • Experience in packaging and labeling of Blood and/or Cells preferred.
  • Technical knowledge relating to materials, equipment, design, and specification writing.
  • B.S. degree in Engineering Packaging, Materials Engineering or Biological Science with 5 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, FDA and global health authority regulations, complex drug and device products.
  • Cold Chain experience desired.
  • Certified Packaging Engineer desired.
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. The level of this position will be based on the final candidate’s qualifications.
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Additionally, 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.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
The pay range for this position at commencement of employment is expected to be between $92,000 and $139,200/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.