Associate Director, Process Analytics, Analytical Development Gene Therapy
Data Science
Durham, NC, USA
Job Description Summary
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.Location: Durham, US #LI-Hybrid
Job Description
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.
Essential for the role:
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.
Desirable for the role:
Experience authoring laboratory Standard Operating Procedures and technical instructions.
Experience supporting regulatory submissions, health authority interactions and technical information requests.
Benefits & Rewards:
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: 145,600.00 to 270,400.00 USD
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Long-term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145,600.00 - $270,400.00
Skills Desired
Analytical Chemistry, Biotechnology, Business Acumen, Chemical Analysis, Chemical Laboratory, Chemical Synthesis, Chemistry, Collaboration, Data Analysis, Deep Learning, Drug Development, Employee Development, Innovation, Machine Learning (ML), Medicinal Chemistry, Molecular Biology, Organic Chemistry, Pharmaceutical Industry, Project Team Management, Results-Oriented, Science, Strategic Planning, Strategic Thinking, Team Management