(Sr.) Scientist, Development (Parenteral Drug Product)

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The Position

As a Senior Scientist in Pharmaceutical Development you will join the Pharmaceutical Development department within Pharma Technical Development (PTD) in Basel Switzerland. Our department is responsible for the end-to-end development of parenteral drug productsincluding both synthetic molecules and biologicsfrom Phase 1 through to market launch. Our activities encompass formulation and manufacturing process development for all clinical stages the transfer of products and processes to commercial manufacturing sites commercial product support and line extension development.

In this position you will serve as an expert in the development and launch of parenteral formulations (e.g. biologics peptides and small molecules). You will play a pivotal role in ensuring our life-saving treatments move successfully from the lab to the patient.

The Opportunity

To thrive in this role you will take on several key responsibilities within our global CMC teams:

• Lead pharmaceutical development of parenteral formulations for clinical development market launch and subsequent line extensions.

• Develop robust manufacturing processes for parenteral liquid and lyophilized formulations including scale-up process characterization validation and transfer to global commercial sites.

• Serve as a Pharmaceutical Project Leader within global CMC teams and act as a functional representative in cross-functional teams and international committees.

• Author and provide critical input for global regulatory submissions across Phases 1-3 and for market applications such as BLA MAA and NDA.

• Evaluate program and submission risks specifically from a drug product formulation and manufacturing standpoint.

• Collaborate across functions to ensure the successful transfer of products and processes to commercial manufacturing environments.

Who You Are

We are looking for a collaborative expert with a strategic mindset and a deep technical background in pharmaceutical development:

• Educational Background: You hold a Ph.D. or Masters degree in Pharmacy Chemistry Biology Biochemistry Chemical/Process Engineering or a related field.

• Industry Experience: You bring a minimum of 6 years of professional industry experience including at least 2 years specifically focused on formulation and process development for parenteral dosage forms.

• Regulatory Expertise: You have proven experience authoring Drug Product (DP) sections for BLA and/or NDA submissions for parenteral molecules.

• Communication & Collaboration: You possess excellent communication skills and stakeholder management abilities characterized by end-to-end and global thinking.

• Technical Plus: Experience in drug delivery systems and associated analytical techniques is considered a strong advantage.

Ready for the next step We look forward to hearing from you. Apply now to discover this exciting opportunity!

Who we are

A healthier future drives us to innovate. Together more than 100000 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.