Associate Director, Analytical Development-Molecular (NGS, ddPCR)

Location
San Diego, CA, US
Posted
May 25, 2021
Ref
4847
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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

She/he will implement feasible strategies and timelines together with the head of Analytical Development for effectively developing, qualifying the robust molecular assays under phase-appropriate GMP by collaborating with the AveXis R & D and QC teams (and/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 and internal transfer. He/she will also represent the AD team in cross-functional team meetings and be critical part of decision-making processes. He/she will be the key member to support the head of AD and the site leadership team in building the positive culture and continued success of AD, in advancing pipeline projects from IND to commercialization.

This role will involve mentoring the growth of lead scientists to their next level by delegating tasks and providing appropriate advice in experimental design, data analysis and presentation. The individual will serve as SME and key decision maker on behalf of AD for topics related to the advancement of robust molecular assays, in cross-functional teams and external team meetings. The individual will also work closely with on-site project managers and global project management organization to support timely communication and ensure project meet development timelines and critical milestones.

Responsibilities
  • Lead, in conjunction with Senior Director of Analytical Development, the Molecular Biology 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 exploring, development, optimization and qualification/validation of robust molecular assays
    • For example, NGS, qPCR, ddPCR and/or other molecular assay platforms to evaluate DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AveXis' AAV-based gene products.
    • Expertise will be based upon:
      • Thorough understanding of relevant molecular assay platforms and applicable bioinformatics tools.
      • Extensive knowledge and strong scientific background related to the products and underlying biology, applicability of the emerging or existing molecular assay platforms and phase-appropriate GMP requirements.
    • NGS experience and molecular biology lab set up experience are highly preferred.
  • Establish and maintain an effective analytical laboratory with full capability to carry out the molecular and other analytical methods. The responsibilities include, but not limited to, overseeing the budget of the Molecular Biology group, ordering and setting up the laboratory.
  • The key liaison to work closely with AveXis AD- Chemistry, AD-Bioassay, R & D, QC groups and project management organization for win-win collaborations in implementing molecular 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 the Analytical Development group to prepare analytical sections of regulatory filings.
  • Present data in major conferences and write/submit manuscripts which will result in win-win achievements for both AveXis and the gene therapy community.

Qualifications
  • Ph.D. in Molecular Biology or related discipline, such as Immunology, Cellular Biology or Genetics
  • Min 10 years of biopharma industry experience with demonstrated track record of successfully developing different molecular biology analytical methods (e.g., next-generation sequencing (NGS) platforms, Sanger sequencing assays, DNA/RNA isolation, primer design, end-point PCR, qPCR, qRT-PCR, droplet digital PCR (ddPCR), , )
  • Next-generation sequencing (NGS) experience and proficiency with various molecular biology and sequence analysis software. (e.g., Miseq sequencer, Geneious, Applied Biosystems 7500, QuantaSoft) is required.
  • Experiences with bioinformatics programming (e.g., Python, R, etc.), is a plus
  • Experiences with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial.
  • Familiarity with virology is a plus.
  • GxP experience is preferred, but not required.
  • Experience in starting up/constructing a molecular, in particular NGS laboratory, in support of the characterization and lot release of clinical and/or commercial product, is highly beneficial.
  • Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hands-on experience, is a plus.
  • Technical writing skills and experience in authoring development reports and SOPs, is required; prior experience in regulatory filings is a plus.
  • Ability to work in a fast-paced, team-oriented environment, to prioritize tasks from multiple projects, and high acumen to organize time-lines/be cognizant of project deadlines.
  • Proven track record to lead a highly effective team.
  • Excellent written and verbal communication skills.


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.

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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