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In Pharma Technical Development PTD, we collaborate to develop robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products. We reliably deliver quality products to patients enrolled in clinical studies around the world. We excel in our work by creating an engaging and inclusive environment where everyone can bring their skills and talents to developing innovative medicines.
As a Section Lead & Center of Excellence (CoE) Strategy Realization in Drug Product Synthetic Molecules Parenterals, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) in Basel, Switzerland.
The department Pharmaceutical Development is responsible for the development of parenteral drug products (Synthetic molecules and Biologics) from Phase 1 through Launch. Activities encompass formulation and manufacturing process development for parenteral drug products for all clinical stages and the market launch, the transfer of product and process to commercial manufacturing sites, commercial product support and line extension development.
This new leadership position is essential for the refinement of the DP SM Parenterals organization. The role is designed to bring clear focus and execution to formulation and process development strategies, while ensuring the team establishes and maintains the necessary capabilities and knowledge management to deliver a complex and growing SM parenterals portfolio.
The successful candidate will be accountable for:
Delivering Portfolio Strategy and Driving Scientific Excellence: Providing clear focus and execution on formulation and process development strategies to successfully deliver the complex and growing SM parenterals portfolio.
Act as a Pharmaceutical Development SPOC for the Research organizations and provide CMC risk assessment and mitigations for molecules entering the portfolio.
Leading, Developing, and Managing Capabilities: You will lead a team of four associate scientists, fostering a collaborative, supportive, and high-performing environment. You will take responsibility for lab equipment capabilities needed to deliver SM DP parenterals.
Ensuring E2E Connectivity and Strategic Influence: Working closely with cross-functional partners (Research organization, CMC experts, Pharmaceutical Development departments) to ensure End-to-End (E2E) connectivity.
CoE Strategy Realization and Unwavering Quality: Acting as the Team Lead & CoE Strategy realization , leading the team's operational focus and strategic direction toward meeting the CoE requirements. Ensure all experimental work in the laboratory adheres to stringent quality standards, maintaining data integrity for non-GMP data in close collaboration within Pharmaceutical Development and Partner functions (e.g. Analytical Development).
You bring the following key skills, combining technical depth with leadership and strategic vision:
Parenteral Expertise: Deep scientific expertise (Ph.D./Master's with 6 years of industry experience) in formulation and process development for parenteral dosage forms.
Team Leadership and Development: Proven ability to lead and inspire a scientific team, manage experimental work, and provide dedicated leadership support for people development and clear accountabilities
Regulatory and Quality Compliance (CMC): Direct experience in writing and reviewing regulatory CMC source and submission documents (e.g., NDA/CTA DP sections), with strong understanding of regulatory landscapes (e.g., ICH guidelines).
Strategic Problem-Solving: A proven team player with a problem-solving mindset and the ability to think end-to-end and globally, managing multiple parallel projects with a structured and rigorous approach.
Analytical methods: Deep expertise in analytical methods to characterize liquid formulations for synthetic molecules
Are you ready to make an impact? Please apply by submitting your updated CV and cover letter via our careers portal.
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Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.