BioPharmaceutical Development (BPD) department supports the advancement of innovative biologics across AZ portfolio, including early research to late-stage development. Within BPD, Process and Analytical Sciences (PAS) develops purification processes and analytical methods for biologic products. The team is also responsible for technology transfers into manufacturing and preparing CMC documentation for regulatory submissions. The team actively implements novel technologies to advance production platform capabilities for high quality therapeutics.
Main Duties & Responsibilities:
This role will focus on viral clearance, part of the protein purification development function in the PAS department. The major responsibilities include:
Design and execute studies to demonstrate virus removal or inactivation capabilities for protein purification unit operations, initially with guidance and gradually become independent.
In collaboration with existing team members, plan studies, manage logistics, documentation, data verification and interpretation, report writing, and participate in regulatory submissions.
Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
Support purification process development, technology transfer to manufacturing sites, and production incident resolution as appropriate.
Participate in new technology evaluations.
Education & Experience Requirements:
Required Education & Experience
Bachelor’s Degree in Biology, Chemistry or related field and 0 years of experience
Preferred Education & Experience
Master’s Degree in Biology, Chemistry or related field and 0 years of experience
Required Skills:
Solid knowledge base in protein chemistry and analytical chemistry.
Some experience in protein purification, including chromatography and filtration methods.
Prior experience in executing experiments to generate reliable results.
Knowledge in good laboratory and manufacturing practices.
Team-player, organized, thoughtful, enthusiastic, passionate about making high quality therapeutics, capable of multitasking.
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