The Process Development and Technology Transfer Principal Scientist, based in San Clemente, CA is responsible for leading the formulation process development and scale up efforts to support Phase 2-3 clinical scale and technology transfer to manufacturing operations for commercial scale up. Responsibilities include qualifying new raw materials (excipients and APls), recommending specifications for products and designing and evaluating product manufacturing processes using quality by design principles for materials and process parameters evaluation and qualification. Leading the formulation optimization and scale up studies based on in-depth understanding of manufacturing processes for solid and semi-solid dosage forms. Serve as a Formulation/CMC Development representative on interdisciplinary and multidisciplinary project teams. Provide leadership for the CMC/Formulation Development and Technology Transfer sub-teams.
• Design and oversee the execution of experiments leading to the development of rational, scientifically sound formulations and manufacturing processes to support the development of sterile ophthalmic dosage forms.
• Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices.
• Support the qualification, calibration and maintenance of R&D equipment in accordance with GLP /cGMPs.
• Ensure compliance with product quality, safety, performance and efficiency.
• Review and apply the compendia requirements for use of excipients.
• DesiQn and execute protocols necessary to complete projects.
• Possess comprehensive knowledge of techniques in areas of solids, liquid and semi-solids dosage forms supporting formulation development and scale.
• Prepare and review scientific documentation such as, laboratory notebooks, data analysis, regulatory reports, master formulas, manufacturing procedures, product development reports and SOPs.
• Prepare written reports for regulatory filings and documents all formulation activities pursuant to cGMP standards.
• Provide leadership to team members on CMC teams .
• Interface with internal (Quality, Operations, Regulatory) and external business partners (CROs, CMOs) on designing and executing product development project plans.
• Develop systems that are cost effective and increase efficiency .
• Maintain and apply current knowledge of cGMP documents and guidance, other FDA/ICH guidance and SOPs.
• Coordinate with analytical chemists for completing testing of new drug products in a timely manner, and developing appropriate controls.
• Provide leadership for the CMC/Formulation Development and Technology Transfer sub-teams. Author the CMC product development sections of regulatory documentation (IND, IMPD, MAA, etc.).
. 8 years of experience in formulating various dosage forms in a pharmaceutical laboratory, including ophthalmic semi-solid dose formulations.
. Working knowledge of experimental designs and clinical manufacturing, validation. and report writing for regulatory submissions.
. Knowledge of product lifecycle - Product and process development, clinical trials. validation and regulatory submissions, commercial GMP manufacturing
. Demonstrated knowledge of pharmaceutical manufacturing of ophthalmic products, sterilization methods, aseptic processing, and process development
. Proficient with interpreting and implementing cGMPs, cGLPs, ICH, USP, FDA, DEA and OSHA guidelines.
. Independent formulation research on enabling technologies and or unique delivery systems
. Excellent interpersonal and verbal/written communication skills that enable effective management and resolution of complex project-related issues involving collaborations with multiple functional areas
. Experience participating or leading tech transfers
. Excellent presentation and communication skills
. Must be able to function and contribute as part of a team. have excellent communication skills and contribute to team based decisions
. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Education: Graduate or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or a related science.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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