Process Engineer API BLA (all genders)
About this opportunity
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.
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 1527 comparable Manufacturing & CMC roles across 125 biopharma companies.
Salary context
456 of 1527 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1527 comparable roles
+ 38 more countries
Seniority mix
705 of 1527 peers have a known seniority level
Therapeutic area mix
7 of 1527 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.