MS&T Specialist

Stefanini Group is hiring!

Stefanini is looking for MS&T Specialist in Davie, FL (Onsite)

For quick Apply, please reach out to Ghanshyam Sharma - call:

/ email:

Work Hours: M-F (40 hours)

Work Location: Davie, FL (Onsite)

Shift: 1st Shift (8:00 AM - 5:00 PM)

This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation, and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including process, cleaning, and packaging validation. Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing, and planning.Maintains expertise related to formulation, raw material properties, and manufacturing processes. Identifies, analyzes, and suggests corrective actions to optimize procedures, processes, materials, technology, and regulatory compliance issues.Digital literacy including basic knowledge of AI (working knowledge of PowerBI, Power Platform, Python, and various presentation tools), JMP, R, etc. is necessary.



Responsibility: Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, and improve safety of the existing commercial products. 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 implement Corrective and Preventive Actions (CAPAs).Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.Evaluate the 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), cleaning agents and contact surfaces, and packaging components. Coordinate the manufacturing activities and prepare technical reports.Execute the 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.Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health, and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.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 introduction, 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.Responsible for performing additional related duties as assigned.



Core essential skill sets required:At least 1 year experience as an MS&T Specialist.Requires a college fresh Ph.D. With chemistry OR Master's degree with pharmaceutical sciences or equivalent and a minimum of twelve months relevant experience in the field of MS&T solid oral pharmaceuticals.Basic certifications in areas of Power Platform, AI, Project Management, preferred.



Skills/Knowledge/Abilities:Ability to efficiently handle and troubleshoot pharmaceutical unit operations, such as high shear granulation, dry granulation (slugging and roller compaction), compression, particle, and tablet coating, pan coating and fluid bed coating, encapsulation, laser drill and packaging, cleaning, etc..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.



Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.



Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.



About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.



#LI-GS1

#LI-ONSITE