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
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