MS&T Specialist I, (Manufacturing, Science & Technology Specialist I)

Job Responsibilities:

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Coordinate manufacturing of batches if required and prepare technical reports.
• Performing continuous process and cleaning verification, statistical assessments and trend analysis for the development and commercial products.
• Performing investigations to identify the root causes and actively seek remediation approaches and implementing Corrective and Preventive Actions (CAPAs).
• Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.
• Execute experimental and process confirmation studies in coordination with planning, manufacturing, quality, LTS and PM groups.
• Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria writes deviation reports and technical assessments as required.
• Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment, CPPs and CQAs identified during pre-validation work.
• Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
• Remediation of the audit related observations (if any) and timely completion of the action items (if any)
• Maintenance of appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard Operating Procedures (SOPs) and internal policies.
• Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
• Leading multiple new product introductions, site transfer projects and cleaning validation activities.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) and Batch Record instructions.

Skills:

• Ability to prepare various types of complex high quality technical documentation (Batch Records (BR), Change Controls (CC), protocols, summary reports, technical assessments, validation reports and deviation/investigation reports etc.
• Ability to handle multiple projects, duties, and assignments.
• Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.

Education/Experience:

• Requires a college fresh Ph.D. With chemistry
• Basic certifications in areas of Power Platform, AI, Project Management, preferred