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Oversee CMC aspects of global submissions, develop processes for marketing applications, lead compilation of regulatory submissions, maintain relationships with global partners, provide regulatory guidance, monitor trends, assemble regulatory responses, interact with regulatory authorities, and keep stakeholders informed.
Seeking a Sr Scientist to join Protein Expression Sciences Department at Regeneron. Responsibilities include creating antibody production cell lines using mammalian expression technologies, developing new technologies utilizing Gene Editing, and conducting various molecular biology techniques. Ideal candidate has a PhD with 0-3 years of postdoctoral experience or a BS/MS with 4-8 years of experience in Immunology, Cell Biology, or Molecular Biology.
The Statistical Programmer provides programming support for clinical studies, implements project standards, collaborates with teams, and maintains documentation for regulatory compliance. Requires proficiency in SAS and knowledge of statistical concepts in pharmaceutical clinical development.
Develop new Quality Control (QC) techniques and procedures for potency assays, apply scientific knowledge to solve complex issues, recognized Subject Matter Expert (SME) in QC, incorporate new assays to increase analytical capabilities.
Supply Compliance Analyst responsible for leading compliance activities within Supply Chain Management. Develops compliance framework, liaises with quality/regulatory groups, facilitates SOP reviews, provides support for document submissions, drives compliance environment, leads investigations, ensures Corrective & Preventative Actions, manages Change Controls, identifies improvement opportunities, and promotes company culture. Requires Bachelor's degree in business, Supply Chain Management, or Science background.
Lead program or study level activities to inform clinical development strategy, study concepts, protocols, and operational plans. Develop and maintain relationships with external experts for country and disease area intelligence. Lead feasibility processes, partner with teams for data validation, support data and analytics functions, engage with external stakeholders, and provide input for continuous improvement.
Support Quality Control Critical Materials and Procurement by compiling and analyzing data, preparing reports, providing updates, and ensuring regulatory compliance. Collaborate with various departments to support manufacturing investigations and validation studies. Maintain data tracking systems and assist in process improvement efforts. Attend meetings to update partners and stay informed on development priorities.
Responsible for configuration, implementation, maintenance, and support of MES areas. Tasks include coordinating enhancement requests, resolving system issues, documentation, configuring reports, providing SME support, and training employees. Requires a degree in Information Technology and experience in technical writing, process mapping, and project management.
Perform chemical and biological analyses on products, in-process materials, or stability samples. Review test results, maintain lab supplies, write procedures, and interact with customers or peer groups. Requires BS/BA in Life Sciences and 2 years of QC experience with HPLC/UPLC and Empower.
Responsible for bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment, performing gels/separations assays, data processing, maintaining reagents and equipment, conducting investigations and generating reports, and implementing lab process improvements.
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