The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network.
We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support.
The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU.
We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate.
In recent years we have successfully established second-generation manufacturing process with continuous process platform.
We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.
The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group.
This group supports commercial operations across a diverse network of manufacturing facilities and external partners.
Key Responsibilities
- Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
- Review manufacturing processes, deviations, and / or development and production data.
- Review manufacturing batch records, protocols, and control strategies.
- Provide technical support and data analysis for investigations and deviation resolution.
- Represent upstream team as an SME or technical lead in cross-site, cross-functional teams.
- Interact with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
- Oversee and report on overall manufacturing progress.
- Design and conduct necessary experiments, interpret results.
- May lead small technical project teams and implement project plans.
- May lead technology transfer efforts of small project teams between groups / organizations.
- May support regulatory filings.
Basic Qualifications
- BS in engineering or science with 5 years of experience OR MS in engineering or science with 3 years of experience.
- Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations.
Preferred Qualifications
- Experience with Good Manufacturing Practices and supporting a commercial facility.
- Experience in cell culture (direct lab experience a plus).
- Experience with equipment qualification and process validation.
- Familiarity with formal root cause analysis and / or risk assessment.
- Experience working with statistical analysis software and investigative data analysis.
- Experience communicating with cross-functional teams.
- Strong technical writing and communication skills.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.
Special Working Conditions
- Ability to gown and gain entry to manufacturing areas.
- Ability to travel (up to 20% of time).
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