CMC Expert Analytical Development focus Parenterals&Devices

Roche Holding AG; Basel; Hybrid; CHF 180,000 - 240,000; Full time

Job summary

Roche Holding AG in Basel, Switzerland, seeks a senior scientific leader to guide analyses and development across NDA and CMC programs. You will mentor teams, drive due diligence, and resolve complex issues, shaping strategic direction and partnerships across R&D functions.

You will leverage extensive pharmaR&D experience to influence roadmaps, maintain scientific excellence, and train staff while collaborating with partners to advance innovative therapies for patients worldwide.

Qualifications

• Advanced degree (Ph.D. preferred) in a relevant scientific discipline.
• Extensive experience in pharmaceutical R&D with analytical development for parenterals and combination products.
• Proven NDA preparation and transfer to commercial manufacturing.
• Strategic problem-solver with strong analytical abilities to mitigate risks and identify opportunities.
• Excellent communicator with ability to influence and collaborate across teams.
• Mentor and guide scientific staff; foster knowledge sharing.

Responsibilities

• Provide expert scientific guidance and strategic input to project teams and leadership.
• Mentor for NDA authoring and drive due diligence processes.
• Lead resolution of complex CMC issues with root-cause analyses and timely solutions.
• Shape scientific strategies and roadmaps from pharma R&D experience.
• Serve as link between cross-functional partners to tackle scientific challenges.
• Drive portfolio-wide risk analysis and implement innovative solutions.
• Lead cross-functional projects to enhance operational effectiveness.
• Train and mentor other scientific staff to foster growth.

Skills

Analytical development expertise

Strategic problem-solver

Excellent communication

Mentoring and training

Cross-functional collaboration

Education

Ph.D. in Pharmaceutical Sciences or related field

Job description

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et a impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.