MS&T Specialist

3 weeks ago

Davie, Florida, United States Aequor Full time
Job Summary

Aequor is seeking a highly skilled MS&T Specialist to join our team in the development and optimization of solid oral dosage forms. The successful candidate will be responsible for performing critical activities related to product and process development, pre-validation, and optimization.

Key Responsibilities
  • Develop and execute studies with Research and Development, Laboratory Technical Services, manufacturing, and planning teams.
  • Maintain expertise in formulation, raw material properties, and manufacturing processes.
  • Identify, analyze, and suggest corrective actions to optimize procedures, processes, materials, technology, and regulatory compliance issues.
  • Provide direction and training to other staff, technicians, and manufacturing operators.
  • Participate in internal and external audits, and remediate audit-related observations.
Requirements
  • PhD in chemistry.
  • At least 1 year of experience as a MS&T Specialist.
  • Excellent communication and problem-solving skills.
Essential Areas of Responsibility
  • Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's), and Batch Record instructions.
  • Complete all training requirements and maintain 100% compliance with all assignments.
  • Adapt Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, and improve safety of existing commercial products.
  • Perform Annual Product Reviews (APRs), statistical assessments, and trend analysis for commercial products.
  • Perform investigations to identify root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).
  • Provide technical assessments/product impact assessment summaries on time to avoid backorder situations.
  • Evaluate Supplier Material Evaluation team changes (SMET) such as changes to the manufacturing process of Active Pharmaceutical Ingredient (API) or site manufacturing changes for raw materials (API, excipients) and packaging components.
  • Execute experimental and process confirmation studies in coordination with planning, manufacturing, quality, LTS, and PM groups.
  • Review and analysis of analytical and statistical data to support pre-validation work.
  • Support pre-validation commercial scale report that includes detailed summary of equipment and qualified equipment parameters (QEPs) assessment, CPPs, and CQAs identified during pre-validation work.
  • Identify and coordinate equipment requirements with R & D, Engineering, Employee Health and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for commercial scale pre-validation development/scale up of ANDA lots.

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