Specialist, Quality Control Stability

Location
Durham, NC, US
Posted
Jul 22, 2021
Ref
6197
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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Specialist, Quality Control Global Stability, Oversees the planning, sampling, execution and data management of program stability studies.

Responsibilities
  • Participates in Stability strategy and protocol design.
  • Writes technical reports; technical report generation (Expiry, Result Record, and APQR)
  • Data management to support the Stability Programs including the administration and distribution of QC stability samples, associated document coordination, and collection and evaluation of data.
  • Serves as the subject matter expert (SME) for stability program related functions.
  • Owner of stability work processes supporting the stability programs.
  • Participates in study design and ensures scheduling of stability lots.
  • Tracks stability time points and evaluates stability data on a routine basis.
  • Document owner for procedures and work instructions in support of stability processes.
  • Owner and assessor of out of trend (OOT) and out of specification (OOS) events.
  • Owner, assessor, and/or reviewer of deviations, change controls, and lab investigations.
  • May generate metrics for stability programs.
  • Reports risks related to stability programs to Quality System Owner(s).
  • Other related job duties as assigned.

Qualifications
  • Bachelors' and/or Masters' Degree in scientific discipline with a technical understanding of biopharmaceutical or Gene therapy production (gene and/or cell therapy development and manufacturing experience advantageous).
  • 5 years of GMP QC/QA lab experience.
  • 4 years of experience in Stability is preferred.
  • Knowledge of Biologics and/or Gene therapy testing methods, validation and qualification.
  • Knowledge of ICH, specifically stability guidelines.
  • Excellent oral and written communication skills with technical writing experience.
  • Expertise in use of MS suite of programs (outlook, excel, powerpoint, word, etc).
  • Ability to work independently, collaboratively, and effectively. Problem-solving aptitude with ability to prioritize and deliver on tight timelines.
  • Understanding of LIMS systems (StarLIMS beneficial): SQL query, language, XML, visual basic, and data generation flow to reporting is beneficial.
  • Experienced quality professional with knowledge of the drug development and quality control process and associated methods.

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-MG1