CMC Expert Analytical Development focus Parenterals & Devices

CMC Expert Analytical Development focus Parenterals & Devices

Roche

Basel, Switzerland

The Opportunity

• Provide expert scientific guidance and strategic input to project teams and leadership within our Analytical R&D department.
• Act as a senior mentor for NDA authoring and drive due diligence processes, providing expert scientific input that shapes key decisions.
• Lead the resolution of complex CMC issues, overseeing root cause analyses and ensuring timely, collaborative solutions.
• Leverage your extensive experience in pharmaceutical research and development to shape our scientific strategies and roadmaps.
• Serve as a critical link between different teams, collaborating with cross-functional partners to tackle scientific challenges and identify new opportunities.
• Drive continuous improvement by analyzing common risks across our portfolio and designing innovative, portfolio-wide solutions.
• Spearhead and implement strategic cross-functional projects, such as R&D Excellence initiatives, to enhance our operational effectiveness.
• Contribute to the future of our team by training, mentoring, and guiding other scientific staff, fostering a culture of knowledge sharing and growth.

Who you are

• You have an advanced degree (Ph.D. preferred) in a relevant scientific discipline such as Pharmaceutical Sciences, Chemistry or a related field.
• You bring extensive experience in pharmaceutical research and development, with deep scientific knowledge in the analytical development of parenterals and combination products with devices ideally including experience with various synthetic molecule modalities like oligonucleotides, peptides or classical small molecules.
• You possess a proven track record of success in NDA preparation and the transfer of projects to commercial manufacturing.
• You are a strategic problem-solver with strong analytical skills, capable of identifying and mitigating scientific risks and opportunities.
• You are a highly effective communicator with excellent interpersonal skills, able to influence and collaborate across diverse teams.
• You thrive in a collaborative team environment, actively participating in scientific discussions and decision-making processes.
• You stay abreast of the latest scientific advancements and trends, continuously applying new knowledge to drive innovation.
• You are a natural mentor, passionate about training and guiding other scientific professionals.