API Manufacturing Scientist

Role : API Manufacturing Scientist - API Manufacturing
Location : Lebanon, IN
Type : FTE/Permanent
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, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), 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 & 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.

Basic Requirements:

• Bachelors in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or master's degree and 1 year experience in cGMP manufacturing.

Additional Preferences:

• Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.
• Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), 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 initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.