• Responsible for process technology transfer from Bioprocess development groups to GMP Operations, including internal and external groups. Conducts facility fit assessments, digital data, and analytics (DDA) activities, and process introduction activities for bioprocessing unit operations. Monitors technical operations of the process through communication with Manufacturing Scientists.
• Represents the Process Technology department at multi-disciplinary matrix teams. Presents results/conclusions at these meetings.
• Responsible for ensuring success of data flows from the manufacturing floor to cloud-based storage systems and collaborating with Data Science and Engineering colleagues across the company.
• Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings. Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions.
• May review and edit batch documentation for cGMP processes.
• Provides training and guidance to Manufacturing Scientists and less experienced personnel.

• Minimum - BA in Molecular science, Biopharmaceutical, Data Science or related field
• Preferred: Biopharmaceutical, Data Science

• Min: 1-3-year Professional work experience
• Preferred: 3+ years of Professional work experience.

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs. But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!) Apply today to join our family and Make Your Mark!