CMC Expert Analytical Development focus Parenterals&Devices

Roche; Basel; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Roche seeks an accomplished scientist to provide expert guidance in Analytical R&D and to lead NDA authoring, due diligence, and cross-functional projects. You will influence strategic directions through deep R&D experience and drive portfolio-wide improvements, mentoring staff to advance scientific excellence.

Located in Basel, this role emphasizes collaboration, regulatory insight, and staying current with scientific trends to shape development strategies and ensure robust, scalable solutions

Qualifikationen

• Advanced degree in a relevant scientific discipline (Ph.D. preferred).
• Extensive experience in pharmaceutical R&D with analytical development expertise.
• Proven NDA preparation and transfer to commercial manufacturing.

Aufgaben

• Provide expert scientific guidance to project teams and leadership in Analytical R&D.
• Lead NDA authoring and drive due diligence processes with expert input.
• Lead resolution of complex CMC issues with root cause analyses and timely solutions.
• Shape scientific strategies and roadmaps using extensive pharma R&D experience.
• Collaborate cross-functionally with teams to tackle scientific challenges and opportunities.
• Drive portfolio-wide risk analysis and innovative, cross-functional improvements.
• Lead strategic cross-functional projects (e.g., R&D Excellence) to boost effectiveness.
• Mentor and train scientific staff to foster knowledge sharing and growth.

Kenntnisse

Analytical development

NDA preparation

Cross-functional collaboration

Mentoring

Problem solving

Scientific strategy

Effective communication

Ausbildung

Ph.D. in Pharmaceutical Sciences or related field

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future, together.

Roche is an Equal Opportunity Employer.