<p>The Technical Support Engineer (Manufacturing Science and Technology) provides critical technical expertise to support GMP Phase 3 clinical trial supply production and future commercial manufacturing of extended-release drug implants. This role serves as the technical bridge between Process Development and Manufacturing, ensuring successful technology transfer, process validation, and continuous improvement of biopolymer-based drug delivery systems produced via extrusion and terminal sterilization.</p> <p>The Technical Support Engineer is responsible for the technical aspects of process scale-up, validation protocol development and execution, process troubleshooting, and maintaining the scientific foundation for manufacturing operations. This role requires understanding of controlled-release drug products, biopolymer systems, and extrusion processes within a GMP environment.</p> <p>This position offers significant career growth potential as the company scales from clinical to commercial operations.</p> <p>Responsibilities</p> <p>Process Development & Technology Transfer</p> <ul> <li>Lead technical transfer activities from Process Development to Manufacturing for extended-release implant manufacturing processes </li><li>Support scale-up activities from clinical to commercial scale, ensuring process robustness and product quality </li><li>Develop and maintain process understanding through characterization studies and design space establishment </li><li>Collaborate with Process Development to optimize manufacturing processes for extrusion, coating, and terminal sterilization operations </li><li>Establish process control strategies and critical process parameters for biopolymer-based drug delivery systems </li><li>Support regulatory filing activities with CMC documentation and technical data packages </li></ul> <p>Validation & Qualification Activities</p> <ul> <li>Author, review, and execute process validation protocols including Process Performance Qualification (PPQ) and concurrent validation studies </li><li>Support equipment qualification activities (IQ/OQ/PQ) for extrusion equipment, sterilization systems, and analytical instruments </li><li>Design and execute process characterization studies to establish design space and prove process capability </li><li>Author validation summary reports and technical assessments for regulatory submissions </li><li>Coordinate with Quality Assurance on validation strategy and compliance requirements </li></ul> <p>Manufacturing Technical Support</p> <ul> <li>Provide real-time technical support during manufacturing operations, including troubleshooting process deviations and equipment issues </li><li>Lead technical investigations for product and process failures, utilizing root cause analysis methodologies (5-Why, Fishbone, FMEA) </li><li>Design and execute Design of Experiments (DOE) to optimize processes and resolve manufacturing challenges </li><li>Support deviation investigations from a process science perspective, providing technical expertise and corrective actions </li><li>Monitor process performance trends and identify opportunities for continuous improvement </li><li>Provide technical expertise for manufacturing process and equipment optimization </li></ul> <p>Risk Assessment & Documentation</p> <ul> <li>Participate in Process Hazard Assessments, quality risk assessments (ICH Q9), and FMEA activities </li><li>Author technical reports, batch records, SOPs, investigation reports, and validation protocols </li><li>Maintain comprehensive technical documentation in compliance with GMP and company standards </li><li>Support regulatory inspections and audits with technical expertise and documentation </li><li>Contribute to change control activities with technical impact assessments and validation requirements </li></ul> <p>Data Analysis & Reporting</p> <ul> <li>Perform statistical analysis of manufacturing and product quality data to support process understanding </li><li>Develop and maintain process monitoring dashboards and control charts </li><li>Present technical findings and recommendations to cross-functional teams and senior management </li><li>Generate technical reports for regulatory submissions and internal decision-making </li><li>Maintain technical databases and process knowledge management systems </li></ul> <p>Requirements</p> <p>Education & Experience</p> <ul> <li>Minimum of Bachelor's degree in Chemical Engineering, Materials Science, Chemistry, Pharmaceutical Sciences, or related technical field </li><li>3-6 years of experience in pharmaceutical manufacturing, process development, or technology transfer </li><li>Experience with controlled-release drug products, biopolymer systems, or drug-device combination products highly preferred </li><li>Knowledge of extrusion processes, or polymer processing technologies is desirable </li><li>Understanding of cGMP regulations (21 CFR 210/211) and ICH guidelines (Q8, Q9, Q10, Q11) </li><li>Experience facilitating technology transfer from laboratory to commercial scale </li></ul> <p>Technical Skills</p> <ul> <li>Proven experience writing and executing validation protocols (PPQ, process characterization, equipment qualification) </li><li>Strong statistical analysis capabilities with proficiency in statistical software (JMP, Minitab, SAS, or similar) </li><li>Experience with Design of Experiments (DOE) methodology and statistical process control </li><li>Knowledge of Process Analytical Technology (PAT) and real-time process monitoring </li><li>Understanding of risk assessment methodologies (FMEA, HAZOP, ICH Q9) </li><li>Familiarity with pharmaceutical analytical methods and specifications for extended-release products </li><li>Experience with process scale-up and manufacturing equipment optimization </li></ul> <p>Specialized Knowledge</p> <ul> <li>Understanding of drug release mechanisms and controlled-release formulation science </li><li>Knowledge of biopolymer properties, processing, and characterization </li><li>Experience with extrusion equipment, process parameters, and troubleshooting </li><li>Understanding of sterilization effects on drug product quality and polymer properties </li><li>Familiarity with regulatory requirements for extended-release products and combination products </li></ul> <p>Professional Skills</p> <ul> <li>Excellent problem-solving abilities with systematic approach to root cause analysis </li><li>Strong written and verbal communication skills with ability to present technical information to diverse audiences </li><li>Project management capabilities with ability to manage multiple priorities and timelines </li><li>Collaborative approach with ability to work effectively in cross-functional teams </li><li>Self-motivated with ability to work independently in a fast-paced start-up environment </li><li>Detail-oriented with strong documentation and technical writing skills </li></ul>