Scientist - API Manufacturing Process Support

Role Summary

The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio, including raw materials, intermediates, enzymes, and bulk drug substances. The role executes technical projects to improve and optimize process control, yield, purity, and productivity, and conducts experiments at the laboratory scale 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 & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Provide support internal and joint process teams and to the global and local PLOT teams.
• Ability to independently set up and execute various chemical reactions.
• Ensure that experiments are well designed with clear objectives.
• Ability to analyze data and ensure appropriate documentation.
• Utilize good laboratory practice and adhere to CHP requirements.
• Write technical reports and documents.

Qualifications

• Required: Bachelor's in a STEM discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
• Required: Master's Degree and 1 year of experience in cGMP manufacturing.
• Preferred: Relevant industrial experience in API Manufacturing, Technical Services/Manufacturing Sciences, Quality Control, Quality Assurance, or Development.
• Preferred: Demonstrated knowledge in small or large molecule API Manufacturing.
• Preferred: Familiarity with cGMP manufacturing environment and terminology.
• Preferred: Excellent analytical, interpersonal, written and oral communication skills.
• Preferred: Ability to work independently as well as part of a team; ability to prioritize activities; good judgment and flexibility.

Skills

• Analytical reasoning and data analysis
• Technical writing and documentation
• Experimental design and troubleshooting
• Communication and collaboration within cross-functional teams
• Laboratory automation and data handling

Education

• Bachelor’s degree in a STEM field (Chemistry focus preferred)
• Master’s degree in a relevant field (preferred)

Additional Requirements

• Tasks require entering manufacturing areas with appropriate PPE.
• Domestic and international travel up to approximately 20%.