Analytical Director
The Analytical Director will report directly to the Chief Technical Officer (CTO) and play a pivotal role in advancing Oculis’ portfolio. This role requires a deep analytical understanding to provide appropriate guidance for the analytical strategy, method development and validation, in line with regulatory guidelines and health authorities’ expectations.
Reports To: Chief Technical Officer
Function: Technical
Level: Director/Senior Director
Location: Lausanne, Switzerland or Reykjavik, Iceland
The role works closely with the CTO and other members of the technical team, as well as cross-functional development teams, to successfully implement and support advancement of Oculis development programs through the product life-cycle from inception to commercialization.
The ideal candidate has a masters or a doctorate degree (MSc, PhD), strong scientific background and leadership capabilities and is eager to further advance the Oculis’ pipeline.
Key Responsibilities
- Lead the development and execution of analytical strategies
- Design and oversee the development, validation, and transfer of analytical methods in compliance with ICH, USP/EP/JP, and regulatory guidelines.
- Support regulatory filings (IND, IMPD, NDA, ANDA, BLA, etc.) by preparing analytical sections of CMC documentation.
- Represent Analytical Development in technical project teams and contribute to strategic project planning.
- Serve as a subject matter expert (SME) during regulatory agency interactions, including preparation for and participation in meetings with FDA, EMA, MHRA, and other agencies.
- Provide scientific justification for specifications, stability protocols, impurity profiles, and analytical methods.
- Interpret complex analytical data and provide risk assessments and mitigation strategies.
- Manage and guide contract testing laboratories (CROs/CMOs) in method development, transfer, and validation activities.
- Ensure all analytical activities are conducted in accordance with GMP, GLP, and regulatory compliance standards.
Necessary Skill Set
- Experience:
Minimum 5+ years (PhD) or 8+ years (MSc) of experience in pharmaceutical analytical development. Proven experience in developing and implementing analytical strategies for small molecules and/or biologics. Solid understanding of global regulatory expectations and ability to draft and defend analytical CMC content in submissions. Hands-on experience with a range of analytical techniques. - Skills:
Deep technical expertise in analytical method development and a strong understanding of regulatory expectations across development stages. Excellent written and verbal communication skills; ability to articulate complex scientific concepts clearly. Proven ability to thrive in a highly fluid, interactive, matrix environment. - Education:
Ph.D or M.Sc. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or closely related field.
Oculis SA is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.