Senior Director, Analytical Development- Gene Therapy

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 Sr. Director, Analytical Development will be a member of the Research and Early Development (R&ED) leadership team and is a key leadership role in Novartis Gene Therapies Research. The candidate will report to the Chief Scientific Officer, Head of Research and Early Development and is responsible for designing integrated analytical strategies, developing and qualifying a full spectrum of innovative and robust analytical methods for adequately characterizing the Novartis' AAV-based gene therapy pipeline assets from research to registration. The successful candidate should demonstrate his/her ability in leading a growing analytical team of three sub-groups with diverse expertise and experience in bioassays (cell-based potency assay and immunoassays), analytical chemistry (HPLC, CE and LC-Mass Spec) and molecular biology (NGS, ddPCR and qPCR). With enriched experience in regulatory aspects, the individual will also serve as the key SME and liaison to closely partner with Quality Control, Technical Operations and Regulatory Affairs for regulatory filings and addressing analytical requests made by Health authorities from IND stage to registration. This individual will also be instrumental in trouble shooting and designing new assays and methods as well providing feedback to guide the product characterization testing criteria in line with the critical quality attributes of Novartis Gene Therapies' product(s). Finally, this individual will be externally active in industry working groups and will be expected to help shape and influence best practices for analytical characterization of gene therapies.

Responsibilities

• A member of San Diego Site leadership and Research and Early Development leadership teams.
• A member of CMC subteam and/or Global project team as needed
• Own and play a key role in shaping the overall analytical strategy and execution plan for Novartis Gene Therapies
• Manage effective collaborative relationships with the key collaborators including Quality, Regulatory Affairs and Technical Operations to deliver corporate goals.
• Closely work with the partners within Research and Process Sciences organizations to expedite the advancement of AAV-based pipeline projects toward successful IND filings.
• Provide technical expertise to guide the development of new and/or improved assays for characterization, stability, and release testing.
• Partner with key collaborators to define short-term and long-term Quality Control strategy and direction.
• Continue to grow and strengthen the high-performing analytical development team of 30+ members and provide timely strategic directions and timelines to the subgroup leaders.
• Provide authorship and/or feedback for the regulatory CMC packages related to the analytical methods for IND filings and applications for approval (BLA/MAA/NDA).
• Provide timely responses to analytical requests from health authorities during the global filings of Zolgensma for ongoing approvals.
• Oversee and ensure the timely delivery of method development, qualification and transfer from AD to QC for GMP lot release and stability study.
• Participate in on-site or virtual health authority CMC inspections of the San Diego site.
• Oversee and ensure the timely delivery of all the post-approval commitments of commercial product Zolgensma to the health authorities.
• Introduce new value-added technology platforms and strategy for product characterization Manage day-to-day operations of the GTx Analytical Development department.
• Develop and maintain the department budget by partnering with the finance department of San Diego site.

Qualifications

• Ph.D. in cellular biology, virology, Molecular Biology, Biology, Genetics, Analytical/Organic Chemistry or other related natural science discipline
• 15+ years of analytical experience in developing, qualifying, validating, and performing analytical tests and assays
• Knowledge in GxP compliance and data integrity is required to ensure smooth transition of the qualified method to the QC laboratories.
• Prior experience in the gene therapy and/or other advanced therapeutics is strongly preferred
• Proven track record of outstanding management and leadership skills to build and oversee a large, high-performing team (30+ members) with diversified expertise including bioassays (cell based and immunoassay based potency, infectivity), analytical chemistry for biotherapeutics (CE, HPLC, mass spec), and genomic assays (NGS, ddPCR and qPCR).
• Demonstrated ability with well-established reputation in developing and qualifying innovative, value-added analytical methods from scratch.
• Diversified experience and knowledge in a wide spectrum of CMC analytics suitable for adequately characterizing AAV gene therapeutics.
• Full understanding of compendial test requirements for sterile parenteral biological drug products and advanced therapy medicinal products
• Contributed first hand to CMC sections of INDs, BLAs, MAAs, etc.

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-JH1