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Specialist, Manufacturing Technical Support

Employer
Novartis Gene Therapies
Location
Durham, NC
Start date
Aug 9, 2022

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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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

The Specialist, Manufacturing Technical Support, provides front line expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards.

 

Please note: Multiple positions are available and will have either Cell Expansion/Upstream or Downstream/Drug Product focus.

Responsibilities

 

  • Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
  • Revises master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis).
  • Ensures that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, and Validation Protocol).
  • Ensures that all process changes in assigned products are managed through appropriate change control procedure.
  • Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records.
  • Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations.
  • Authors manufacturing investigations and meets all targets for timely closure and CAPA completion.
  • Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs.
  • Performs first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
  • Provides and supports assessments of technical changes, establishment of root-cause analysis, Quality Risk Assessment and process control strategies.
  • Maintains processes at inspection readiness level.
  • Supports process optimization establishment and new technology introduction for continued productivity improvement.
  • Reviews validation protocols and reports for technical correctness.
  • Supports the execution of process validations, and short-term improvement projects, collaborating with all the relevant parties at shop floor to ensure accurate execution. Launch and Transfer– for the product(s) assigned.
  • Revisions to the master manufacturing documents of assigned products.
  • 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 or 3 years relevant experience with Novartis Gene Therapies (GTx).
  • Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations.
  • 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(~20%).

 

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?

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!

 

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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. 

 

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