Scientist II, Injectable Drug Product Development

In this Senior Scientist role, the candidate will lead the research, design and execute scientific studies to enable the drug product (DP) process development, characterization, and commercial validation of parenteral/injectable biologic products. The candidate will lead the development of a variety of manufacturing unit operations including, but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation.

Hands‑on experience with biotherapeutics drug product development, including a detailed understanding of the manufacturing unit operations is required. An understanding of protein chemistry, formulation, and biopharmaceutical assay (e.g. HPLC, CE, iCE, HIAC, MFI, etc.) development as well as the ability to run biopharmaceutical assays in a laboratory is necessary.

The candidate will also be responsible for manufacturing technology transfer activities, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as at-scale/full scale process development studies, protocols, and reports. Experience with supporting deviations, change controls, and Corrective Actions/Preventive Actions utilizing electronic Quality system such as Vault Enterprise Quality Vault (EQV) is desirable.

In addition, the candidate will provide clinical and commercial manufacturing site support including but not limited to weekly/biweekly support meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-functional staff from Analytical Development & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, CMC, and/or CMC Regulatory Affairs.

Experience with electronic record keeping and data software, like electronic lab notebooks, End Note, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/Graph Pad, JMP, Visio, and Adobe Pro, would be an advantage.

• Leading drug product development teams with multiple cross functional stakeholders, as well as understanding the cross functional implication of project activities and decisions. Making scientific/technical proposals based on corporate or project objectives.
• Independently designing and executing development studies for Alexion pharmaceuticals’ drug candidates and commercial products, supporting technology transfer activities for internal manufacturing and contract manufacturing sites
• Understanding 'big pictures' for projects and tasks involved and prioritizing work of self and others accordingly. Prioritizing multiple assigned tasks and projects and leading project teams comprising of one or more junior team members. The ability to work independently as well as part of the team is essential.
• Performing in depth data analysis as well as authoring technical reports and or relevant sections of clinical and commercial regulatory filings on the executed studies for the Alexion drug product candidates
• Be current with the literature about drug product manufacturing processes, manufacturing equipment, and single use systems as well as associated global regulatory expectations.
• Communicating effectively with peers and management. Actively participating in department and team meetings including assuming ownership and delivering on assigned action items.
• Developing presentations for meetings with internal and external stakeholders with minimal supervision.