Associate Director, Process Analytics, Analytical Development Gene Therapy

NovartisDurham, CA
$145,600 - $270,400Hybrid

About The Position

What if your scientific leadership could help accelerate the next generation of gene therapies for patients with serious and life-changing diseases? As Associate Director, Process Analytics, Analytical Development Gene Therapy, you will play a pivotal role in shaping the analytical strategy that supports innovative cell and gene therapy programmes from development through technology transfer. Working at the intersection of science, strategy and leadership, you will lead talented teams, provide technical oversight across complex development activities, and influence critical programme decisions. This is an exciting opportunity to join a growing Gene Therapy Analytical Development organisation and help advance cutting-edge therapies that have the potential to transform patients' lives.

Requirements

  • PhD in Biology, Chemistry, Biochemistry, Biotechnology, Biomedical Engineering or a related scientific discipline.
  • Significant experience supporting analytical development within the cell and gene therapy field.
  • Strong expertise in analytical methods used for cell and gene therapy process development.
  • Proven people leadership or matrix leadership experience within a scientific environment.
  • Deep understanding of scientific principles underpinning analytical development and biologics development.
  • Strong knowledge of phase-appropriate compliance expectations within regulated development environments.
  • Excellent communication and presentation skills, with the ability to influence cross-functional stakeholders.
  • Demonstrated problem-solving, decision-making and technical leadership skills in complex development programmes.

Nice To Haves

  • Experience authoring laboratory Standard Operating Procedures and technical instructions.
  • Experience supporting regulatory submissions, health authority interactions and technical information requests.

Responsibilities

  • Lead analytical strategy and testing activities supporting cell and gene therapy process development programmes.
  • Provide technical oversight for process development, optimisation, characterisation and technology transfer activities.
  • Serve on the Gene Therapy Analytical Development Leadership Team, shaping organisational goals and strategy.
  • Lead, coach and develop scientists to deliver high-quality results and achieve programme objectives.
  • Partner with cross-functional stakeholders across development, manufacturing, quality and regulatory functions.
  • Drive technical assessments and influence key programme decisions through scientific expertise and insight.
  • Author, review and approve analytical documentation, ensuring accuracy, quality and compliance.
  • Champion laboratory innovation, supporting technology evaluation, adoption and laboratory expansion initiatives.
  • Present technical findings, project updates and strategic recommendations to senior leaders and stakeholders.
  • Support regulatory submissions, health authority interactions and responses to technical information requests.

Benefits

  • Insurance plans
  • Retirement plans
  • Wellbeing resources
  • Global recognition programs
  • Flexible and hybrid working options
  • Minimum 14 weeks paid parental leave

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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