(Senior) Principal Process Engineer and Strategy Realization Lead

(Senior) Principal Process Engineer and Strategy Realization Lead page is loaded

(Senior) Principal Process Engineer and Strategy Realization Lead

Apply locations Basel time type Full time posted on Posted 2 Days Ago job requisition id 202505-112380

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

As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development.

As an integrated partner within the drug development ecosystem, Global Biologics Pharmaceutical Development is dedicated to effectively developing innovative and patient-centered parenteral drug products including Formulation and Process Development and Drug Delivery Systems.

The (Senior) Principal Process Engineer and Strategy Realization Lead ensures robust clinical and commercial process designs for effective process validation and successful commercialization. The incumbent is responsible for the development of drug product processes for the holistic parenteral DP process development portfolio , running from Biologics, synthetic molecules, peptides to Gene & Cell Therapy . This includes overseeing the development of filling, lyophilization, and freeze/thawing processes, applying Quality by Design (QbD) principles where appropriate, and executing process characterization and validation programs. The role will provide process design and validation support for drug product transfers across the network and offer engineering support for equipment and processes.

Furthermore, you will collaborate within the Global Drug Product Process Engineering group to drive strategy harmonization and oversee seamless harmonized strategy deployment and right-first-time clinical and launch technology transfers and major market approvals. Harmonizing work across technical development functions and other Pharma Technical Operations network partners is crucial for success. A key component of the role involves providing strategic guidance across the DP process engineering network, ensuring the team's work supports the broader PTD Parenterals Development organization, including clinical and commercialization development phases, Drug Delivery, and Device Departments.

The Opportunity

As an experienced (Senior) Principal Process Engineer and Strategy Realization Lead with expertise in process development and launch experience in parenteralia, you will play a crucial role in driving strategy harmonization and leading drug product process development within our global team. Your key responsibilities:

• Develop, optimize, and validate robust processes for clinical and commercial parenteral drug products.

• Lead process design, validation studies, and technical transfers for seamless commercialization.

• Collaborate cross-functionally and across the parenteralia pipeline portfolio to ensure strategic alignment and successful project execution.

• Foster innovation and continuous improvement in drug product and equipment processes.

• Ensure compliance with GMP and regulatory standards.

Who you are

Our ideal candidate will meet the following criteria:

• While a Ph.D. in a related scientific or engineering field is preferred, all candidates possessing equivalent experience are encouraged to apply.

• 10+ years of biopharmaceutical industry experience and proven ability to lead cross-functional teams.

• Experience with implementing advanced Process Analytical Technologies and/or drug device combination product processes is a plus

• Expertise in parenteral process development and regulatory submissions.

• Strong (VACC) leadership and project management capabilities.

• Excellent communication, strategic thinking, and problem-solving skills.

Interested to join our innovative team and help shape the future of pharmaceutical development? Apply now!

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.

About Us

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.