Process Development Engineer
This role will require the candidate to provide process development support to new product introductions and lifecycle changes, ensuring a seamless transition from development to commercialization.
Key Responsibilities
* Lead new product introductions and lifecycle changes into PM2 and PM3 from a Process Development perspective.
* Serve as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
* Contribute to regulatory filings as part of the NPI process throughout the authoring, editing and submission process.
* Respond to regulator questions as and when required.
* Act as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products.
* Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
The ideal candidate will have a strong background in process development, with experience in supporting commercial protein drug product processing. A PhD or Master's degree in Science or Engineering is preferred, along with 5+ years of experience in a similar role. Strong knowledge of cGMPs and other worldwide regulatory requirements is essential.
As a key member of the team, the successful candidate will be responsible for developing and characterizing drug product processes, transferring technology to commercial drug product sites, and identifying operational opportunities for current and new sterile operations. The candidate will also lead and conduct risk assessments for drug product operations and propose/implement appropriate CAPA.
Additionally, the candidate will provide support to the PD forensic lab and serve as a link to manufacturing on key investigations as a process expert. They will develop validation plans, process performance qualifications (PPQs) for vial and syringe filling, and ensure that all aspects of activity within any given process validation adhere to required policies and procedures.