Biologics Drug Substance/Drug Product Technology Transfer Engineer ( AZ15643)
Essential Job Functions:
• Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with AZ and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.
• Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
• Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.
• Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.
• Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.
• Note: The AZ team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.
• Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.
o B.S with 10+ years of experience
o M.S. with 6+ years of experience
o PhD with 4+ years of experience
• Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
• Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
• Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
• Ability to work in a complex, dynamic, global environment