Senior Manager, Quality Control

Location
San Diego, CA, US
Posted
Oct 08, 2020
Ref
5656
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
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 leader to lead the dynamic and growing Quality Control (QC) department at the San Diego site. The individual will manage the site QC operations to support development and commercialization of new gene therapy medicines.

Responsibilities
  • Manage the Quality Control laboratory activities and capabilities to provide timely and cGMP compliant testing for in-process, release, and stability samples in a high-growth, fast-paced, and dynamic work environment
  • Collaborate with Analytical Development and/or outside contract labs to ensure seamless method qualification, validation, and transfer
  • Develop departmental expertise with respect to testing and documentation required to satisfy legal and regulatory requirements for product release
  • Lead to evaluate, procure, and qualify necessary instruments
  • Develop strong working relationships with Analytical Development, Manufacturing, QA and MS&T to achieve company objectives
  • Define strategic objectives for the site QC department and implement initiatives to improve compliance and efficiency.
  • Ensure proper investigation into the root cause of product and/or process failures, and assist in determining appropriate product disposition and/or process improvements
  • Build a strong team and foster talent management, including performance and succession planning, to support the company's business objectives

Qualifications
  • Advanced Degree in Chemistry, Biology or related sciences. Ph.D. degree preferred.
  • Minimum 6 years of experience in pharmaceutical QC testing laboratory
  • 3+ years of direct supervisory experience
  • Comprehensive knowledge of cell-base assays required.
  • Experience in method qualification, validation, and transfer
  • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building
  • Strong strategic thinker with business acumen
  • Comprehensive knowledge of cGMP regulations


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