MSAT Engineer II
4 weeks ago
We are seeking a highly skilled MSAT Engineer II to join our team at AGC Biologics. As a key member of our process development team, you will be responsible for leading the implementation of drug substance tech transfer, scale-up, and commercialization strategies.
As a MSAT Engineer II, you will interact extensively with internal stakeholders and clients to support the drug approval process. Your expertise will be essential in creating and maintaining process validation protocols and reports, as well as ensuring compliance with FDA/EMA/ICH regulations.
This is a unique opportunity to work with a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and contribute to the development of innovative therapies for patients worldwide.
Key Responsibilities- Lead the implementation of drug substance tech transfer, scale-up, and commercialization strategies
- Interact with internal stakeholders and clients to support the drug approval process
- Create and maintain process validation protocols and reports
- Ensure compliance with FDA/EMA/ICH regulations
- Develop and maintain strong relationships with Process Development, Manufacturing, Quality Control, and Quality Assurance teams
- 2+ years of relevant industry experience
- BS/MS in Engineering
- Technical competency in Drug Substance process and/or manufacturing requirements
- Experience with GMP manufacturing or other scientific laboratory procedures
- Demonstrated proficiency with Microsoft applications
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. We are an equal opportunity employer and welcome applications from diverse candidates.
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