Joseph Griego
Manufacturing Science & Technology Technical Services Scientist @Tolmar
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WORK HISTORY
Manufacturing Science & Technology Technical Services Scientist @Tolmar
Windsor, CO, US
Responsible for providing scientific support for the QA/QC, regulatory, manufacturing, and development groups. Essential Duties & Responsibilities• Perform process and formulation optimization for commercial product line to achieve financial goals of product improvement activities.• Prepare scientific documentation describing and supporting process changes and improvements for regulatory submissions.• Lead process improvement efforts with designated projects in areas including formulations, optimization and scale-up.• Serve as a company resource, providing technical direction. • Make scientific recommendations to management as to the acceptability and quality of affected product lots.• Participate in the generation and compilation of technical data required to support post approval changes. • Assess the technical feasibility and serve as a technical liaison for incoming contract manufacturing/development work.• Participate in development/commercial project timeline meetings.• Mentor less experienced members of the team.Knowledge, Skills & Abilities • Solid knowledge of analytical, formulation and process development techniques encompassing skills associated with troubleshooting, process optimization and scale-up.• Demonstrated proficiency with technical assessments, scientific creativity, and collaboration with other functional area.• Strong working knowledge of different drug product types, including semi-solids.• Demonstrated experience in technical writing as evidenced by scientific publications, presentations, etc.• Solid knowledge of ICH, SUPAC, and cGMP Guidelines.• Knowledge of pharmacokinetic and pharmacodynamic principles.
ABOUT JOSEPH GRIEGO
An array of experience in the FDA regulated pharmaceutical industry• Excellent knowledge of cGMP, FDA regulations and industry standards• Subject Matter Expert (SME) for solid oral dose pharmaceuticals• Proficient skills in the areas of root cause analysis and process optimization• Experience with product development, validation and product/process troubleshooting • Experience with process improvement and operational excellence to optimize products/processes • Experience of auditing of raw material suppliers and assessing raw material supplier changes• First line of contact for troubleshooting off-hour technical issues• Ability to prepare and review critical technical documentation related to regulatory filings, audit responses, product impact assessments, etc. • ASQ Certified Quality Auditor
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