Manager, (Development) Quality Control

Location
San Diego, CA, US
Posted
Jul 18, 2021
Ref
6113
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

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 Manager, Development Quality Control will oversee testing and support the design and development of tests, studies, procedures, and specifications for the Novartis Gene Therapies pre-clinical, clinical, and commercial material programs. This includes cGMP release and characterization testing using analytical techniques such as PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting). This position will lead a group of staff who will have expertise in execution of analytical testing.

Responsibilities
  • Oversees/manages testing labs and works closely with manufacturing organizations.
  • Lead the development, qualification, validation, and transfer of analytical methods.
  • Interpret characterization, product release, and stability data.
  • Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.
  • Work closely with the regulatory team to provide analytical documentation to the FDA and international regulatory agencies during regulatory submissions.
  • Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
  • Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
  • Recruits, develops and mentors staff and provides support to ensure successful accomplishment of business goals.
  • Perform other related duties as assigned.

Qualifications
  • Bachelor's Degree in Chemistry, Biology or related sciences.
  • Minimum 8 years of relevant experience in pharmaceutical testing laboratory. Two (2) years prior leadership experience strongly preferred.
  • Strong working knowledge of protein chemistry and analytical test methodologies: Immunoassays, PCR, chromatography, and electrophoresis.
  • Prior experience with biologics, QC, stability, IND submissions, BLA or NDA submissions is important for success in the position.
  • Understanding of applicable USP, ICH, and Ph Eur regulations as they relate to QC testing is also highly desirable.
  • Expertise in use of Excel or comparable software solutions for management and analysis of data.
  • Outstanding problem-solving abilities.
  • Ability to work independently and effectively.
  • Ability to prioritize and deliver on tight timelines.
  • 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.
  • Good critical thinking, deductive reasoning, and decision-making skills.
  • Approximately 10% travel.


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