RocheCMC Expert Analytical Development focus Parenterals&Devices
Roche is hiring a CMC Expert Analytical Development focus Parenterals&Devices in Basel, Switzerland. Level rates it ; you can apply on Roche.
Level's read on this job
- Little AI ●○○○ is how Level rates this role: aI is not part of the work.
- The posting mentions analytical development, pharmaceutical research and root cause analysis among its tools and skills.
- Level classes it as a senior role.
- Roche has 1,200+ other open roles on Level.
AI in this role
Provide expert scientific guidance and strategic input to analytical R&D projects focusing on parenterals and combination products.
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.
How we rate this
CMC Expert Analytical Development focus Parenterals&Devices at Roche rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where analytical development was part of your work. What did you do?
- Tell me about a project where pharmaceutical research was part of your work. What did you do?
- Tell me about a project where root cause analysis was part of your work. What did you do?
- Tell me about a project where regulatory authoring was part of your work. What did you do?
- Tell me about a project where project management was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Analytical Development, Pharmaceutical Research, Root Cause Analysis, Regulatory Authoring, and Project Management. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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