About the role

Aplyr's Quick Take

This role is for a Process Engineer focused on insulin manufacturing, specifically in driving process improvements and ensuring compliance with regulatory standards. You'll be involved in troubleshooting, process validation, and technology transfer, working closely with various teams. It's primarily an individual contributor role with some leadership responsibilities.

Good fit

Ideal candidates have an advanced engineering degree and experience in pharmaceutical manufacturing, particularly with APIs. You should be detail-oriented, collaborative, and comfortable in a fast-paced environment.

Worth noting

The position emphasizes a strong understanding of regulatory frameworks and requires proficiency in both German and English. The focus on biologics and the transition of insulin to biologic classification may be a unique opportunity for those interested in cutting-edge pharmaceutical developments.

To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume with your application.

Position Overview

We are looking for two individuals to support and drive process engineering activities for our Project API insulin manufacturing operations, ensuring compliance with cGMP, HSE, and regulatory (BLA) requirements. Contribute to process development, robustness studies, process validation, and continuous improvement to ensure the performance of biological drug substances (insulin).

Lead equipment packages and systems from Design to qualification.

The API BLA (Biologics License Application) context refers to the regulatory transition of insulin to biologic classification.

Main responsibilities:

Support manufacturing operations for insulin API (E. coli-based fermentation), including troubleshooting major deviations and driving continuous improvement initiatives
Contribute to the regulatory transition of insulin as a biologic, supporting BLA submissions and ensuring processes meet regulatory standards
Drive and support process validation campaigns, robustness studies, and process improvement projects
Participate in technology transfer activities between R&D CMC and manufacturing, leveraging the co-located R&D site
Develop and maintain process engineering standards and practices (P&IDs, process models, equipment design)
Support capital and improvement projects related to insulin API manufacturing
Work closely with Quality, HSE, Regulatory Affairs, and Production teams

About you

Education/Experience: advanced Engineering degree (Chemical, Biochemical, Bioprocess, or related field); Experience in pharmaceutical/biopharmaceutical manufacturing, ideally in API or Drug Substance production; experience with process validation and technology transfer in regulated environment; familiarity with E. coli fermentation and downstream processing (chromatography, depth filtration) is a strong asset
Soft and technical skills: Knowledge of cGMP regulations and biologics regulatory frameworks (BLA/MAA); strong leadership ability to lead equipment packages/systems; highly collaborative, detail-oriented, and resilient in dynamic project environments
Languages: proficiency in german and English required

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€79.104,00 - €105.472

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

Aplyr's read

Sanofi is a leading global healthcare company specializing in therapeutic solutions for complex diseases, attracting professionals passionate about innovation in human health.
Synthesized from recent postings & public sources

What's promising

•Sanofi has a strong focus on innovative therapies for diabetes, oncology, and rare diseases.
•The company invests heavily in research and development, ensuring a robust pipeline of new treatments.
•Sanofi's global presence offers diverse career opportunities in various healthcare sectors.

What to watch

•The pharmaceutical industry faces intense regulatory scrutiny, which can impact Sanofi's operations.
•Sanofi's competitive market requires constant innovation to maintain its leadership position.
•Global operations may lead to complexities in supply chain and regulatory compliance.

Why Sanofi

•Sanofi's emphasis on rare diseases sets it apart in the pharmaceutical industry.
•The company has a dedicated focus on immunology, offering specialized career paths.
•Sanofi's commitment to global health solutions differentiates it from competitors.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Sanofi

Sanofi

sanofi.com

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Sanofi is a global healthcare company focused on human health. It develops and provides therapeutic solutions in areas such as diabetes, oncology, immunology, and rare diseases.