Specialist I ,MSAT

Position Summary

The Specialist I, MSAT will provide technical support to optimize commercial manufacturing processes and commercialize new products and technologies. This role is responsible for supporting project activities for new product introductions into the Monroe site. This will include activities such as scale-up batches, equipment/systems qualifications, exhibit/registration batches, and process/cleaning validations. In addition, this role is involved in continuous improvements through data analysis, regulations updates, and industry standards applicable to aseptic/sterile drug products.

Job Responsibilities

• Detect gaps in the manufacturing process, potential for process improvements/optimization, and work in teams to resolve technical issues in manufacturing and ensure adequate process capability and control for all products.
• Understand pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting, equipment & facility qualifications, computer system validations, and cleaning validation.
• Learn Manufacturing Operations of Sterile/Parenteral formulations and related equipment (as applicable for the sites).
• Develop protocols for scale-up and optimization, exhibit, pre-validation, process performance qualification, hold time studies, and investigational studies based on a risk-based approach.
• Support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishment of the root cause using a data-driven and science-based approach.
• Attend technical training concerning CQAs, CMAs, and CPPs, improve manufacturing processes and process controls.
• Perform statistical evaluations (Running Chart, Box plot, Regression analysis, Cpk, and Ppk) of data and logically interpret data using Minitab/JMP software.
• Coordinate with cross-functional teams and assist in resolving problems encountered during batch production and investigation (as required), assess timelines, and ensure resolution per the timelines.
• Prepare validation protocols and reports as per guidelines and regulatory requirements. Qualify manufacturing equipment/systems/instruments.
• Learn new processes and equipment independently.
• Show good problem-solving and critical-thinking skills.
• Show high mechanical aptitude and ability to learn and understand new technical information.
• Show ability to gown and work on the production floor in an aseptic manufacturing environment.
• Show proficiency with Microsoft Word, Microsoft Excel, and PowerPoint.

Qualification and Skills

• Minimum-B.S. in Pharmaceutical Sciences / B.S. Engineering preferred, MS in Pharmaceutical Sciences / MS in Engineering.
• Specialized training in Statistics, and Six Sigma certifications.
• Understanding of material science (AVD).
• Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility.
• Problem-solving & technical decision-making, relationship building, innovation and creativity, teamwork & collaboration, result orientation, time management, agility, and adaptability.