We are searching for an Analytical Project Leader to support Analytical Research & Development (ARD) in project management. ARD, situated within the Technical R&D department at Novartis, plays an essential role in the characterization and analysis of drug substances and products, overseeing them from the discovery laboratories until their transfer to commercial production. We seek a highly motivated and experienced Analytical Project Leader with expertise in oligonucleotide analytics.
About the Role
Your main responsibilities include:
Being part of a global CMC subteam that leads the technical development of drug substances and products from early to late-phase clinical development.
Managing analytical activities within a Technical CMC project team, including defining control and specification-setting strategies for drug substances and products of small molecule new modalities (e.g., xRNAs).
Leading an analytical subteam, preparing analytical project plans, and ensuring compliance with quality, timelines, and budget for assigned projects.
Accurately forecasting FTE and cost demands for your assigned projects.
Issuing analytical source documents in a timely manner (e.g., specifications, validation reports, stability reports, etc.).
Providing scientific inputs to analytical CMC documents and supporting regulatory submissions.
Collaborating with internal and external stakeholders in drug development and coaching analytical experts.
Leading outsourced analytical activities at CROs/CDMOs and managing external partnerships.
Educational Background
PhD in analytical chemistry or equivalent with a minimum of 5 years of experience in the pharmaceutical industry, preferably in analytical development for sterile parenteral products. Experience with oligonucleotide analytics is a plus.
Proven knowledge of early or late-phase parenteral development and filings.
Demonstrated leadership experience in managing development projects, ideally in a global matrix environment.
Strong understanding of regulatory guidelines for analytical development.
Collaborative spirit, self-driven attitude, and a high level of learning agility.
Robust quality focus and experience in a cGMP environment.
Intrinsic motivation to work with new development compounds, willing to go the extra mile for success.
Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences with the ability to perform in a highly dynamic environment.
Good scientific and technical writing skills.
Familiarity with novel digital tools to enhance productivity in a global project management setting.
Proven leadership in guiding and coaching colleagues.
Excellent communication skills and ability to be a role model.
Fluency in English (oral and written); proficiency in German or French is an advantage.
Commitment to Diversity and Inclusion
Novartis is dedicated to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodation to all individuals. If you require accommodation for any part of the recruitment process or need detailed information about the essential functions of this position, please send an email to Show e-mailm"> with your request and contact information. Don't forget to include the job requisition number in your message.
Why Novartis?
Helping individuals battling disease and their families requires more than innovative science; it demands a community of smart, passionate people like you. Together, we can achieve breakthroughs that significantly impact patients' lives. Ready to create a brighter future together?
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