Senior Process Development Scientist III

Design, execute, and author technical development reports utilizing Quality by Design (QbD) principles to support new product formulation, aseptic filling, and lyophilization cycle development.

Lead process scale-up, technology transfers into commercial manufacturing facilities, and troubleshooting investigations for existing commercial and clinical pipeline products.

Perform routine and specialized analytical testing (HPLC, Karl Fischer, DSC, spectroscopic techniques) in support of product characterization and stability studies.

Prepare, author, and review cGMP-compliant technical documentation including standard operating procedures (SOPs), Master Batch Records, validation protocols, and technical reports for US FDA regulatory filings.

Support root-cause investigations, deviation resolutions, and Corrective and Preventive Actions (CAPA) related to manufacturing scale-up.

Mentor and direct the daily technical activities of junior Process Development scientists and laboratory technicians.

Conduct hands-on benchwork across laboratory, pilot plant, and cleanroom environments adhering to strict EHS protocols.

Operate specialized pilot equipment including laboratory/pilot-scale lyophilizers, fume hoods, temperature controllers, and analytical testing balances.