CMC Expert Analytical Development focus Parenterals&Devices

Reposted 10 Days Ago
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Basel, Basel-Stadt
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Provide expert guidance in Analytical R&D, mentor teams, resolve CMC issues, drive strategic projects, and enhance operational effectiveness.
Summary Generated by Built In

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.

Ready to bring your unique qualities to Roche and make an impact? Apply now and join us in our mission to shape the future of healthcare.

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.

Top Skills

Analytical Development
Chemistry
Nda Preparation
Pharmaceutical Sciences
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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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