Analyst, Quality Control

Location
Durham, NC, US
Posted
Jun 10, 2021
Ref
6021
Discipline
Quality, Quality Control
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 Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

Novartis Gene Therapies is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The individual will collaborate closely with Analytical Development team to qualify/validate analytical methods and establish the site QC lab operations to support development and commercialization of new gene therapy medicines. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations.

A potential candidate should have enriched experience in culturing transformed and primary cells and banking cells. In addition, experience in testing samples using qualified cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site.

Responsibilities
  • Perform cell-based potency and impurity assays for in-process, release, or stability samples.
  • Perform other established analytical methods such as qPCR and CE to support QC operations.
  • Participate in assay troubleshooting, qualification and validation if needed.
  • Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems.
  • Write and revise documents such as SOPs and technical reports.
  • Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.

Qualifications
  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field, or 4 years relevant experience in lieu of degree.
  • Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
  • ability to communicate and work in a team environment
  • Normally receives detailed instructions on all work


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.