API-EM TS/MS-Organic Synthetic Lab Scientist

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Organization Overview:

The primary focus of API-EM TS/MS-small molecule scientist is to execute laboratory projects (experimental, investigational, and lab modeling) to improve and optimize process control, yield, purity, and/or productivity supporting APIEM technical agenda initiatives.  The TS/MS – small molecule scientist should be technically independent in setting up and executing a variety of reactions at laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS small molecule laboratory.  The secondary focus of the scientist will be to provide technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, and bulk drug substances.    

Responsibilities:

• Ability to independently set up and execute various chemical reactions.
• Apply technical expertise to scientific problem solving to support TSMS
• Ensure that experiments are well designed with clear objectives
• Ability to analyze data and ensure appropriate documentation
• Utilize save laboratory practice and adhere to CHP requirements
• Write technical reports and documents
• Ability to work in a team environment and contribute to small molecule technical projects in the laboratory
• 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, 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.
• Provide support to the global and local PLOT teams.
• Provide support to internal and joint process teams.

Basic Requirements:

• Demonstrated basic knowledge in chemical synthetic in a laboratory settings.  Relevant industrial experience in API Manufacturing, small molecule development, or discoveries.

• Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.

Additional Preferences:

• Strong problem solving skills,
• Excellent analytical, written and oral communication skills.
• Familiarity with cGMP manufacturing environment and terminology.
• Ability to work independently as well as part of a team.
• Ability to prioritize activities.
• Good judgment and flexibility.

Additional Information:

• Tasks require entering manufacturing areas which require wearing appropriate PPE.
• Domestic and international Travel (variable, can approach 10%).

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