Director/Senior Director, Process Development

Director/Senior Director, Process Development

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.

The Role

The Director/Senior Director, Process Development is accountable for and leads all aspects of process development for Audentes' novel AAV production processes and for the recently-implemented internal Plasmid Operations function.  This role is responsible for leading development activities starting from Research, progressing into initial process development to support pre-clinical/toxicology studies and Phase I/II clinical trials, through characterization of the process to support Phase III/registrational activities including Process Performance Qualification (PPQ) and licensure. Process Development also has responsibilities for the manufacture of research-grade material for use in assay development and Research/non-clinical studies. Given that many of these activities are on the critical path, Process Development coordinates development-related activities working closely with the broader CMC and project teams to ensure successful execution and on-time completion of deliverables.

The specific responsibilities of this position include:

  • Set the strategic vision: plan, prioritize, and manage resources and budgets for Audentes Process Development to support the company's increasing array of AAV-based programs through establishment of goals, plans, and performance metrics that are periodically reviewed and reported to the wider organization
  • Provide leadership and direction to both the AAV and Plasmid process development functions, which are responsible for the following primary deliverables:
    • Upstream and downstream process development and characterization, from pre-clinical through PPQ and licensure
    • Manufacture of non-GMP materials for non-clinical and research studies
  • Oversee the successful development and transfer of robust processes (upstream, downstream, fill/finish, and plasmid) that meet or exceed the programs' target product profiles and other key objectives (e.g., yield, COGs, impurity profiles)
  • Develop and lead manufacturing process innovation initiatives intended to broaden Audentes' leadership role in AAV manufacturing
  • Identify and champion new methodologies, technologies, and/or improved production modalities to increase yields, potency, and purity
  • Communicate to CMC and project teams to ensure timely dissemination of information (e.g., experiment schedules, titers, yields, impurity levels, etc.) and delivery of materials
  • Generate and/or approve technical reports, and author relevant CMC sections for regulatory submissions and other HA interactions
  • Provide technical support to internal Manufacturing and external CMOs and vendors

Required Education, Skills and Experience

  • Bachelor's degree in life science or engineering field and 10+ years related experience in the biotechnology or pharma industry within a process development function
  • 3+ years' experience managing, mentoring and leading teams. Strong people management skills with proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage staff
  • Direct experience designing and implementing experiments to evaluate processes for protein- and virus-based therapeutics or vaccines
  • Experience with:
    • Both mammalian and bacterial process development
    • Developing and optimizing both upstream and downstream unit operations
    • Process/tech transfer to internal and/or external GMP manufacturing organizations
  • Energetic, flexible, collaborative, and proactive leadership and management skills to grow and develop a Process Development team of scientific and engineering professionals
  • Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders
  • Understanding of cGMP requirements
  • Proven experience with regulatory submissions
  • Strong planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
  • Able to work in a fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables
  • Strong computer skills including MS Office (Word, Excel)
  • Commitment to Audentes' values: Be BOLD, Care deeply, #GetStuffDone

Preferred Education, Skills and Experience

  • MS or PhD degree
  • Experience with late-stage development and process characterization/validation in support of product licensure is highly desired
  • Familiarity with gene-based therapies and specifically AAV
  • Familiarity with plasmid DNA/RNA production
  • Familiarity with working on programs that are for rare disease indications

Job Details

Reference # R-201904TJ
Posted on 11 Apr 2019
Closes on
Location(s) South San Francisco
Department Tech Operations/Manufacturing
Career level Management
Hours/Status Full-time
More details (document)
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