MS&T Specialist II

Job Description

Job Description

Description : MS&T Specialist

Shift Schedule : Monday - Friday 8 am – 5 pm

Duration : 1 year contingent assignment

Davie, FL

Temp to Perm role : Possibility based on workers performance and openings

Core essential skill sets candidates must have to be considered for the role :

1. At least 1 year experience as a MS&T Specialist

2. College fresh PhD with chemistry or college fresh Master’s degree with pharmaceutical sciences or equivalent

3. Basic certifications in areas of Power Platform, AI, Project Management, preferred

POSITION SUMMARY

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.

ESSENTIAL AREAS OF RESPONSIBILITY

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.

• Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, 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.

POSITION REQUIREMENTS

Any equivalent combination of education, training and / or experience that fulfills the requirements of the position will be considered.

Education / Certification / Experience :

Skills / Knowledge / Abilities :