MS&T Specialist

Responsibilities:

• Adapt Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, and enhance product safety.
• Coordinate batch manufacturing as required and prepare technical reports.
• Perform continuous process and cleaning verification, statistical assessments, and trend analysis.
• Conduct investigations to identify root causes and implement corrective and preventive actions (CAPAs).
• Provide timely technical assessments and product impact summaries to prevent back-order situations.
• Evaluate Supplier Material Evaluation Team (SMET) changes, including API manufacturing process and raw material changes.
• Coordinate manufacturing activities and execute experimental/process confirmation studies with internal teams.
• Review and analyze analytical/statistical data to support pre-validation work.
• Ensure data meets protocol and acceptance criteria; prepare deviation reports and technical assessments.
• Support preparation of pre-validation commercial scale reports, including assessment of equipment parameters, CPPs, and CQAs.
• Identify and coordinate equipment requirements with R&D, Engineering, EHS, and PM teams for capital expenditure requests.
• Participate in internal and external audits (e.g., FDA, MHRA) and address related observations.
• Maintain documentation of protocols, reports, and laboratory notebooks per SOPs and policies.
• Provide technical support during commercial pre-validation, manufacturing, and quality activities.
• Lead new product introductions, site transfer projects, and cleaning validation activities.
• Ensure compliance with cGMPs, SOPs, and safety standards.
• Complete required training and maintain 100% compliance with all assignments.
• Perform additional duties and projects as assigned.

• Strong ability to troubleshoot pharmaceutical unit operations such as high shear granulation, dry granulation (slugging/roller compaction), compression, particle coating, pan/fluid bed coating, encapsulation, laser drilling, packaging, and cleaning.
• Ability to prepare high-quality technical documentation (Batch Records, Change Controls, protocols, reports, validation documents, deviation reports).
• Strong problem-solving skills with the ability to manage multiple projects and assignments.

• Knowledge of pharmaceutical unit operations and process troubleshooting.
• Strong technical writing and documentation skills.
• Ability to solve practical problems and adapt to limited standardization.

• Ph.D. in Chemistry (Entry Level Candidates considered).
• OR Master s degree in Pharmaceutical Sciences (or equivalent) with at least 12 months of relevant experience in MS&T solid oral pharmaceuticals.
• Preferred certifications: Power Platform, AI, and Project Management.