Contd from H.10B. experience in oral solid dosage formulation and process development to include any relevant job titles in these occupations; experience must be in the pharmaceutical industry.br br In H.12, job requirements are normal for the employer due to the complexity of job duties associated with this position and common in the industry. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Developing conventional and enabling solid oral dose formulations and related manufacturing unit operations, including Dry Granulation, Wet Granulation, Milling, Blending, Compression, and Film Coating. 2. Design of Experiment DoE, execution, characterization, and data analysis during formulation screening stage. 3. Applying cGMP requirements for drug product development and manufacturing. 4. Working with crossfunctional groups, including preformulation, earlystage product development, analytical development, clinical, quality and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures GLP, GMP, and ICH. 5. Supporting drug product manufacturing at CDMOs for phases 1, 2 and 3 of clinical studies. 6. Conducting and coordinating conventional and enabling formulation feasibility screening and assessments, technology selection and product development activities internally and externally. 7. Performing research studies to support preformulation, formulation, and process development of oral solid dosage forms. 8. Designing and optimizing prototype formulations, conducting inhouse experiments, and transferring technology to CDMOs for manufacturing CTMs. 9. Performing material characterization flow, compressibility, and particle size distribution of lab and pilot scale manufacturing process of pharmaceutical unit operations. 10. Performing FMEA and risk assessment during formulation and process development. 11. Authoring technical documents for formulation and process development and contribute to preparation of CMC sections for regulatory filings IND, NDA, and MAA. 12. Working with cross functional groups Analytical, Quality, and Regulatory to ensure all drug product requirements are met. 13. Generating drug formulation data and documentation, including data summaries, technical reports, scientific presentations, and regulatory documents. Position requires 15 domestic and 5 international travel; expenses paid by employer.
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