Process Development, Senior Scientist – Drug Product Summary of job description: Working in collaboration with cross functional teams, the Process Development Senior Scientist will provide subject matter expertise and practical technical support for drug product production processes, optimization and improvement of drug product production procedures, process characterization, and process validation in support of commercialization.
In addition, there will be opportunities to participate within important projects across the whole production process as they arise.
Key responsibilities: Development and execution of process characterization experiments for fill / finish production steps (e.g.
automated filling systems, visual inspection, labeling and freezing of the drug products) Management of the cGMP drug product visual inspection program.
Liaison to external vendors for process equipment / materials specifications, user requirements, procurement, and technical support Author protocols, reports, risk assessments, SOPs, and batch records Act as the accountable point of contact from the Process Development organization for product/process support for technology transfers and ongoing cGMP drug product manufacturing.
Use technical experience to troubleshoot issues with drug product processing technologies and equipment.
Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions.
Assist with authoring sections of applicable regulatory filings.
Drive continuous improvement in our cGMP process steps through technological innovation and application of experimental findings.
Lead functional and cross functional teams to achieve company goals.
Other Responsibilities: Practices and promotes safe work habits and adheres to safety procedures and guidelines Provide technical representation during internal and external audits Keeps up to date with current technologies and trends in drug product processing Some travel may be required, both in country and international Educational requirements: Master’s degree and 4 to 6 years of related work experience OR Bachelor’s degree and 6 to 8 years of related work experience Experience and skill requirement: Minimum of 4 years working in biologics drug product process development / manufacturing support role.
Experience with setting up, supporting, and troubleshooting multiple pieces of drug product manufacturing equipment (e.g.
fill machine, labeler, semi-automated VI systems) Experience with single-use manufacturing technologies.
Experience conducting process characterization with minimal supervision.
Demonstrated ability to work in cross-functional teams across the business.
Strong organizational skills and attention to detail.
Excellent written and oral communication skills and strong team player