Senior Specialist, Lab Systems

Location
San Diego, CA
Posted
Sep 28, 2021
Ref
2021-6293
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

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 Senior Specialist, Lab Systems, responsible for the lifecycle management of GxP lab systems in the Gene Therapy (GTx) analytical labs in Novartis Technical Research & Development (TRD) from concept, development, validation, implementation and maintenance to retirement.

Responsibilities

  • Acts as the SME for GxP lab systems such as LIMS, Empower, and other analytical instruments in the analytical labs in TRD GTx.
  • Ensures the GxP lab systems are in compliance to all regulatory requirements such as 21 CFR Part 11 and Annex 11.
  • Day-to-day management and continuous improvement of all GxP lab systems/processes.
  • Plans and leads large GxP system projects, such as LIMS implementation and lab instrument qualification.
  • Works with Development Quality, IT, Engineering, and Validation to support GxP lab system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement.
  • Authors,  reviews, reports on and approves corrective actions to protocols, investigations, non-conformance, CAPAs, and other records related to GxP lab systems.
  • Leads data integrity initiatives related to GxP lab systems.
  • Reviews, identifies, and leads  implementation of improvements to existing lab systems.
  • Overseas/Creates SOPs and training related to GxP lab systems.
  • Lead representation of GxP lab systems during meetings.
  • Oversees and/or communicates and tracks all follow-up items through to completion.
  • Other related duties as assigned.

Qualifications

  • Bachelor's degree in a Scientific, Biotech, Pharmaceutical or IT field with 8 years' relevant experience working in a GxP pharma or biotech environment.
  • 3 years instrument administration experience.
  • 3 years' experience with LIMS administration
  • 3 years' experience with chromatography data systems, especially Waters Empower®.
  • Advanced working knowledge of Windows permission settings, network domain, and a general understanding of server architecture is a plus
  • Working knowledge in SQL, Java, or other LIMS programming language.
  • Experienced in lifecycle management of GxP lab systems.
  • Up to 10% travel.

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. #LI-AR1

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