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

Role Summary

Associate/Sr. Associate Manufacturing Scientist - Peptides - Lebanon API. The Manufacturing Scientist provides technical support to achieve reliable and compliant manufacturing of API molecules, executes technical projects to improve process control, yield, purity, and productivity, and conducts experiments at laboratory scale 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/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, 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 & 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

• Bachelor‚Äôs in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or Master‚Äôs degree and 1 year experience in cGMP manufacturing.
• Demonstrated knowledge in peptide synthesis (Preferred).
• Relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development (Preferred).
• Familiarity with cGMP manufacturing environment and terminology.

Skills

• Excellent analytical, interpersonal, written and oral communication skills.
• Ability to work on own initiatives and as part of a Process Team with diverse professionals.
• Creativity to identify improvement opportunities and initiative to implement them.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Education

• Not specified beyond the Basic Requirements (Bachelors in STEM or Master‚Äôs as noted).

Additional Requirements

• None listed beyond the travel/physical demands not specified as essential.