Associate/Sr. Associate Manufacturing Scientist - Peptides - Lebanon API

Role Summary

Associate/Sr. Associate Manufacturing Scientist - Peptides - Lebanon API. The Manufacturing Scientist supports reliable and compliant manufacturing of API molecules within the TSMS (Technical Services/Manufacturing Science) team, providing daily oversight to ensure safe and reliable supply of medicines. The role executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and productivity, and conducts laboratory-scale experiments for process improvements and troubleshooting.

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 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, Validation Master Plans, Operational and Process Control Strategy, 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 (batch production records 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.
• Investigate deviations using appropriate tools to ensure quality of the product.

Qualifications

• Required: Bachelors in a STEM discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or Masters degree and 1 year experience in cGMP manufacturing.
• Preferred: Demonstrated knowledge in peptide synthesis; relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development; familiarity with cGMP manufacturing environment and terminology; excellent analytical, interpersonal, written and oral communication skills; ability to work on own initiatives and as part of a Process Team; creativity to identify improvement opportunities and drive implementation; guidance/mentoring of others; flexibility to meet business needs.

Skills

• Analytical, interpersonal, written and oral communication skills
• Ability to work independently and as part of a diverse Process Team
• Creativity to identify and implement improvements
• Mentoring and guidance of others through processes
• Adaptability to meet business needs

Education

• Bachelors in STEM (Chemistry preferred) or Master's degree in a related field