Director, Analytical Development

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking an experienced and exceptional individual to lead the group of bioassays with 8+ talented scientists responsible for developing functional cell-based, immunoassays and biochemical assays. The individual will be overseeing and establishing the adequate and value-added assay platforms suitable for the characterization and lot disposition of clinical and commercial gene therapy drug products.

She/he will implement feasible strategies and timelines together with the head of Analytical Development for effectively developing, qualifying and/or validating the MOA-reflective or surrogate potency assays under phase-appropriate GMP by collaborating with AveXis R & D team and QC (or CROs) in support of development and commercialization of AveXis/Novartis new gene therapy medicines. The individual will serve as tech lead for the assay transfers both for outsourcing or internal transfer. He/she will also represent the AD team in the cross-functional team meetings and be part of decision-making process. He/she will be the key member to support the head of AD and site leadership team in building the positive culture and continued success of AD in advancing the pipeline projects from IND to commercialization.

The role will involve mentoring the growth of the scientists to next level by delegating tasks and providing appropriate advice in experimental design, data analysis and presentation. The individual will serve as SME and decision maker on behalf of AD on the topics related to bioassays including potency assays on behalf of AD either in cross-functional teams and external team meetings.

Responsibilities

• Lead, in conjunction with Senior Director, Analytical Development, the Analytical Development function in establishing near-term and long-term overall strategies, goals, execution plans and timelines as well as resource allocations and budget planning.
• Key driver to oversee the development, optimization and qualification/validation of MOA-reflective (or surrogate) cell-based potency assays suitable for lot disposition and stability study based upon thorough understanding of the scientific background of the products and underlying biology, applicability of the emerging or existing bioassay platforms and phase-appropriate GMP requirements.
• Establish and maintain an effective analytical laboratory with full capability to carry out the cell-based and other analytical methods. The responsibilities include, but not limited to overseeing the budget of bioassay group, ordering and setting up the laboratory.
• The key liaison to work closely with AveXis AD-Analytical Chemistry, R & D and QC groups for win-win collaborations in implementing cell-based and other functional assays and characterizing the key attributes of new gene therapy pipeline products.
• Represents the analytical team to attend cross-functional CMC and project meetings and to actively participate in strategy design, execution, data presentation and follow-up.
• Authors technical reports and SOPs and assists the Head of Analytical Development group to prepare analytical sections of regulatory filings.
• Present the data in the major conferences and write and submit the manuscripts which will be win-win for both AveXis and the gene therapy community.

Qualifications

• Ph.D. in biology discipline is required.
• 10+ years of biopharma industry experience with demonstrated track record of successfully developing different spectrum of cell-based and molecular assays by using methodologies such as cell imaging systems, flow cytometry, ELISA, gel and Western blot, PCR and qPCR assay platforms etc.
• Experience in starting up an analytical laboratory in support of the characterization and lot release of the clinical and commercial biologics.
• Background in biological therapeutics such as antibodies, vaccines or gene therapy are required.
• Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a plus.
• Technical writing skills and experience in authoring development reports and SOPs are required, Prior experience in regulatory filings is a plus.
• Ability to work in a fast-paced team environment and to prioritize work from multiple projects, highly goals and deadlines oriented.
• Proven track record to lead the highly effective team.
• Excellent written and verbal communication skills.

This position is located out of our La Jolla area facility and may require up to 10% travel between La Jolla, third party vendors (domestic) and our HQ and Manufacturing sites located in the Chicago area.

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.

AveXis 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.

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