Job Title- MS&T Specialist

Location- Davie FL 33314

Location : 12 months contract (Possible Extension)

Shift Schedule : Monday - Friday, 8 : 00 AM 5 : 00 PM

Temp to Perm : Possibility based on performance and openings

Position Summary :

The MS&T Specialist is responsible for executing critical activities related to product and process development, optimization, and validation of solid oral dosage forms, particularly after the filing of Abbreviated New Drug Applications (ANDA).

This role involves collaboration with various departments, including Research and Development (R&D), Laboratory Technical Services (LTS), manufacturing, and planning to ensure the successful launch and lifecycle management of pharmaceutical products.

The specialist will maintain expertise in formulation, raw material properties, and manufacturing processes, providing technical direction and training to other staff members, technicians, and operators.

Core Essential Skill Sets :

Experience : Minimum of 1 year as an MS&T Specialist.

Education : PhD in Chemistry.

Safety & Compliance : Maintain work areas and perform job functions in a safe, efficient manner in accordance with company policies, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Record instructions.

Training & Development : Complete all training requirements and maintain 100% compliance with assignments.

Operational Excellence : Adapt Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, and enhance safety.

Coordinate additional batch manufacturing as required and prepare technical reports.

Annual Product Reviews : Conduct Annual Product Reviews (APRs), statistical assessments, and trend analysis for commercial products.

Investigations & CAPAs : Perform root cause investigations, seek remediation approaches, and implement Corrective and Preventive Actions (CAPAs).

Technical Assessments : Provide timely technical and product impact assessments to avoid backorder situations.

Supplier Material Evaluation : Evaluate and coordinate manufacturing activities related to changes in manufacturing processes of Active Pharmaceutical Ingredients (APIs), excipients, and packaging components. Prepare technical reports.

Pre-Validation & Process Studies : Execute experimental and process confirmation studies in collaboration with planning, manufacturing, quality, LTS, and PM groups.

Data Analysis : Review and analyze analytical and statistical data to support pre-validation work, ensuring data meets protocol and product acceptance criteria.

Write deviation reports and technical assessments as required.

Commercial Scale Pre-Validation : Support pre-validation commercial scale reports, summarizing equipment and qualified equipment parameters (QEPs) assessment, CPPs, and CQAs identified during pre-validation work.

Equipment Requirements : Coordinate equipment needs with R&D, Engineering, Employee Health and Safety (EHS), and PM groups in preparation of Capital Expenditure Requests (CERs) for the commercial scale pre-validation development and scale-up of ANDA lots.

Audit Participation : Participate in internal and external audits, including Corporate, QA, FDA, and MHRA audits. Address audit observations and complete action items promptly.

Documentation : Maintain appropriate documentation of protocols, reports, and laboratory notebooks as per SOPs and internal policies.

Product Introduction & Site Transfer : Lead multiple new product introductions and site transfer projects.

Additional Duties : Perform other related duties as assigned.

Position Requirements :

Education : Requires a PhD in Chemistry.

Experience : At least 1 year of experience as an MS&T Specialist, or any equivalent combination of education, training, and / or experience that fulfills the requirements of the position.

Please E-MAIL your resume (attachment to email) with rate and availability to Aditya :

Last updated : 2024-09-07