Senior Process Scientist

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Job description

Senior Process Scientist

Leads, authors and supports complex process-related investigations for the supported products and supports investigations lead by others (by providing clearly documented technical memos).
Writes strong technical documents related to Manufacturing and Quality Support (i.e. QEs, discrepancies and support to complaint investigations), Process Optimization (i.e. DOE 's), and other technical protocols to support the process (which may include Aseptic Processing Validation (Media Fills), Process Validation, Experimental protocols) and, other Technology Transfer activities.
Supports the technical related aspects of the manufacturing processes (i.e. investigations, complaints evaluation, change controls).
Supports pharmaceutical process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of manufacturing systems including change control and CAPA actions towards optimization manufacturing processes to assure effectiveness, robustness, and compliance.
Monitors the commercial processes to ensure material inputs, process equipment, procedures, and controls to continually deliver product meeting specifications including periodic monitoring of on the floor activities.
Performs process FMEAs and other process verification activities per current Regulatory Guidelines with process validation.
Partners with automation, manufacturing, and Information Management to ensure manufacturing processes are appropriately described in the Manufacturing Batch Record, (whether manual or electronic) per process description (as outlined in CMC documentation) and; escalates to site leadership when gaps in process capability are identified.
Supports the design, execution and evaluation of process validation and process justification protocols to ascertain the required process capabilities, specifications and robustness including the authoring of high quality technical reports requiring minimal review.
Provides timely and efficient technical support to qualified/validated systems/processes/products and writes comprehensive technical reports to document all process improvement or investigation projects.
Designs, develops and conducts process studies/projects aimed at process optimization to improve efficiency and reduce operating costs and; recommends, propose and formalize alternatives for the optimization of validated or new processes.
Plans and coordinates new and ongoing projects to assure successful and timely execution issuing and updating detailed time and event schedules.
Performs raw material characterization studies to support vendor qualification programs and to offer source alternatives.
Evaluates and appraises Process/Equipment changes in regards to regulatory requirements.
Assess products/processes performance for new or existing products utilizing statistical tools and other techniques.

Requirements:

Bachelor Degree in Pharmacy, Chemistry, Engineering or any other related Science field.
• Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for parenteral and biological dosage forms.
• Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting.
• Proficient knowlege of biopharmaceutical formulation processes, parenteral filling, lyophilization and syringe filling processes.
• Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations.
• Detailed understanding of how parenteral manufacturing process are controlled and validated.
• Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to technology transfer and scale-up activities.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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