Single-Use Systems Expert - all genders - Fixed-term contract until 31.10.2025

at  Sanofi

About the job
Our Team:
MSAT (Manufacturing, Science, Analytics and Technology) Injectables Frankfurt mission is to ensure successful maintenance and transfer-in of innovative drug products (monoclonal antibodies = mAB, microbial proteins) to SFB&O (Site Frankfurt Biologics & Oncology), and life cycle management (LCM) activities of marketed insulins products for ICF (Insulin Campus Frankfurt).
Our Galenics team, which is part of MSAT Injectables Frankfurt, is supporting the products transfer and LCM activities by process development studies and by the implementation and maintenance of Single Use Systems.
As Single Use Systems expert, you will be part of the Galenics team. You will be responsible for the evaluation (Extractables & Leachables, Filter Validation) of single use technology (e.g. filters, tubings, bags, assemblies) and development/establishment of new disposables used for the production of injectable drug products (mAB, microbial proteins and insulins) filled at the above mentioned Sites.

Main responsibilities:

• Extractables & Leachables (E&L) and Filter validation assessment
• Collect the necessary technical information
• Compile the available technical information and perform the assessment
• Coordinate the review and approval according to project timelines
• Plan, coordinate and perform E&L and Filter Validation studies with external companies
• Work in close cooperation with the product team according to the project needs
• Act as primary process owner for filter validation and E&L incl. presentation of relevant topics during audits and share expertise on a global level (e.g. in a “Community of Practice”)
• Support regulatory dossier preparation and answers to Health Authority questions
• Support Change Control and Deviation process
• Support trouble shooting activities concerning Single Use Technology
• Creation of GMP documents (e.g. SOPs, risk assessments, specifications)

About you

Education and professional Experience

• Master in science (e.g. Pharmacy, Chemistry, Biotechnology)
• Professional experience in the pharmaceutical industry preferably in Quality Assurance or in Drug Product manufacturing

Soft skills

• Precise way of working even under pressure
• Good organization skills
• Ability to work in a regulated, international environment in diverse teams
• Good communication and presentation skills

Technical skills

• Profound MS-Office knowledge

Languages

• Very good knowledge in German and English (in writing & verbally), additional languages advantageous

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, disability, or gender identity.
Watch our
ALL IN video
and check out our Diversity Equity and Inclusion actions at
sanofi.com
!
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

• Extractables & Leachables (E&L) and Filter validation assessment
• Collect the necessary technical information
• Compile the available technical information and perform the assessment
• Coordinate the review and approval according to project timelines
• Plan, coordinate and perform E&L and Filter Validation studies with external companies
• Work in close cooperation with the product team according to the project needs
• Act as primary process owner for filter validation and E&L incl. presentation of relevant topics during audits and share expertise on a global level (e.g. in a “Community of Practice”)
• Support regulatory dossier preparation and answers to Health Authority questions
• Support Change Control and Deviation process
• Support trouble shooting activities concerning Single Use Technology
• Creation of GMP documents (e.g. SOPs, risk assessments, specifications