CMC Expert Analytical Development focus Parenterals&Devices

F. Hoffmann-La Roche AG; Schweiz; Vor Ort; EUR 150.150 - 193.050; Vollzeit

Zusammenfassung

Roche offers an advanced scientific leadership role in Analytical R&D, emphasizing NDA guidance, due diligence, and strategic CMC input. You will mentor staff and shape scientific roadmaps while collaborating with cross-functional teams to tackle complex challenges.

The position focuses on analytical development of parenterals and combination products with devices, guiding risk analyses and implementing portfolio-wide improvements.

Qualifikationen

• Advanced degree in a relevant field with emphasis on pharmaceutical sciences
• Extensive experience with NDA preparation and transfer to manufacturing
• Proven ability to guide complex CMC issues and risk analyses
• Strong communication and collaboration across diverse teams

Aufgaben

• Provide expert scientific guidance to project teams and leadership
• Lead NDA preparation and due diligence efforts
• Drive resolution of CMC issues and root cause analyses
• Mentor and train scientific staff across global teams

Kenntnisse

NDA guidance

Analytical development

Cross-functional leadership

Mentoring

Strategic thinking

Ausbildung

Ph.D. preferred

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.

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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.