Associate/Sr. Associate Manufacturing Scientist - Small Molecule - Lebanon API

Role Summary

Associate/Sr. Associate Manufacturing Scientist - Small Molecule - Lebanon API. The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects to improve and optimize process control, yield, purity, and/or productivity. The role includes setting up and executing experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.

Responsibilities

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Provide technical support for preparation of relevant technical documents, such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Develop and monitor established metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Ensure that an accurate instruction set (tickets and procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Ensure that experiments are well designed with clear objectives.
• Ability to analyze data and ensure appropriate documentation.
• Write technical reports and documents.

Qualifications

• Bachelors in STEM Discipline (Chemistry preferred)
• 2+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred)

Skills

• Demonstrated understanding of process chemistry
• Knowledge in small molecule, peptide, or oligonucleotide API Manufacturing
• Experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development
• Familiarity with cGMP manufacturing environment and terminology
• Analytical, interpersonal, written and oral communication skills
• Ability to work independently and as part of a diverse Process Team
• Creativity to identify improvement opportunities and the initiative to implement them
• Mentoring of others through processes
• Flexibility to meet business needs