Quality Control Specialist (Global QC) / PCR or NGS

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.

The Quality Control (QC) Specialist provides Chemistry and Biochemistry expertise at a site. This includes technical writing, routine testing, and all other associated activities. The QC Specialist responsibilities include, but are not limited to, training, sampling, routine testing, method qualification/validations, investigations, and technical writing. A potential candidate will possess a strong understanding of QC testing techniques. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, and personal development. The QC Specialist may also support the Manager for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Specialist should be able to work effectively within the group, within Quality, and across site.

Responsibilities

• Perform Chemistry and Biochemistry testing, including PCR and/or Next Generation Sequencing (NGS)
• Serve as subject matter expert in this area representing Quality Control during audits and inspections.
• Review and trend data and publish quarterly and annual trend reports.
• Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
• Participate in assay troubleshooting, qualification and validation.
• Manage the use and maintenance of scientific equipment and instrumentation, computer systems.
• Write and revise documents such as SOPs and technical reports.

Qualifications

• Minimum B.A. or B.S. in scientific related field.
• Minimum of 5 years in a GMP Quality Control laboratory.
• Prefer candidates with Next Generation Sequencing (NGS) experience
• Working knowledge of multiple assays.
• Experience with method validation and qualification.
• Experience leading small teams and projects.
• Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
• An excellent and persuasive communicator.
• Energetic, flexible, collaborative and proactive.

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-GK1