The Process Development Scientist is responsible for developing and optimizing manufacturing processes for the production of pharmaceuticals, biologics, or other therapeutic products. The primary objective will be to design and implement robust and scalable processes that meet quality, yield, and cost targets. As a PDS, you will apply scientific principles to drive process improvements and ensure successful technology transfer to manufacturing.
Responsibilities
Design and develop efficient and scalable manufacturing processes for the production of pharmaceuticals, biologics, or therapeutic products.
Conduct feasibility studies, process characterization, and optimization experiments to identify critical process parameters and establish process control strategies.
Apply statistical tools and Design of Experiments (DOE) to analyze data and optimize process performance.
Implement process improvements to enhance product quality, yield, and efficiency while reducing costs.
Collaborate with research and development teams to ensure successful scale-up of processes from lab-scale to pilot-scale and eventually to commercial production.
Conduct technology transfer activities, including process documentation, training, and support for manufacturing teams.
Participate in process validation activities, including the design and execution of process validation protocols.
Establish appropriate control strategies, including the definition of process limits, control ranges, and in-process controls.
Conduct risk assessments and implement risk mitigation strategies throughout the process development and manufacturing phases.
Work closely with cross-functional teams, including research scientists, engineers, quality assurance, and regulatory affairs, to ensure alignment and successful execution of process development objectives.
Communicate effectively with internal stakeholders and external partners, providing updates, progress reports, and technical support as needed.
Prepare and maintain accurate and detailed process development documentation, including protocols, reports, batch records, and standard operating procedures (SOPs).
Qualifications
Bachelor's, Master's, or Ph.D. degree in a relevant scientific or engineering discipline (e.g., chemical engineering, pharmaceutical sciences, biochemistry).
Proven experience in process development, process optimization, and technology transfer in the pharmaceutical, biotechnology, or related industries.
Strong knowledge of process characterization, statistical analysis, and process control principles (e.g., Design of Experiments, Statistical Process Control).
Familiarity with regulatory requirements and industry guidelines for pharmaceutical manufacturing (e.g., FDA, EMA).
Proficiency in process modeling and simulation tools, statistical software, and data analysis techniques.
Excellent problem-solving skills and ability to troubleshoot process-related issues.
Strong written and verbal communication skills.
Ability to work effectively in cross-functional teams and collaborate with stakeholders at different organizational levels.
Attention to detail and ability to prioritize multiple tasks.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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