Quality Control Analyst (In vitro Bioassay)

Location
San Diego, CA, US
Posted
Aug 24, 2020
Ref
4945
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

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 Quality Control (QC) Analyst who will collaborate closely with the 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.

The individual 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 identification and implementation of corrective and preventive actions. The individual 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 ELISA, 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
  • Minimum B.A. or B.S. in biochemistry or related scientific field.
  • Prefer experience with in vitro bioassay, ELISA, cell based, qPCR
  • Minimum of 1-year GMP lab experience and at least 2 years of industry experience working on tissue culture and cell-based assays associated with biologics products.
  • Excellent oral and written communication skills with strong technical writing experience required.


The level of this position will be based on the final candidate's qualifications.

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