Senior Scientist – Manufacturing Science

Role Summary

Senior Scientist – Manufacturing Science responsible for technical support to enable reliable and compliant manufacture of the API External Manufacturing portfolio, executing projects to improve process control, yield, purity, and productivity, and independently setting up and conducting laboratory-scale experiments for process improvements and troubleshooting.

Responsibilities

• Understand scientific principles for manufacturing intermediates and bulk drug substances, including chemistry and equipment interactions.
• Execute technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, purity, and productivity.
• Provide technical support for preparation of 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 real-time metrics to assess process variability and capability.
• Justify and document validation state (process and cleaning) with data evaluating manufacturing process capability.
• Ensure accurate instruction sets (tickets & procedures) and PFD describe the process and control strategy for discrete manufacturing steps.
• Provide support to internal and joint process teams and to global and local PLOT teams.
• Independently set up and execute various chemical reactions.
• Design experiments with clear objectives; analyze data and ensure proper documentation.
• Adhere to good laboratory practices and CHP requirements.
• Write technical reports and documents.

Qualifications

• Basic Requirements: 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Additional Preferences: knowledge in small molecule API Manufacturing; familiarity with cGMP manufacturing environment and terminology; excellent analytical, interpersonal, written and oral communication skills; ability to work independently and in a team; ability to prioritize activities; good judgment and flexibility.

Education

• PhD or equivalent in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.

Additional Requirements

• Complete learning plan for API EM TS/MS Scientist.
• No certifications required.
• Tasks require entering manufacturing areas with appropriate PPE.
• Domestic and international travel up to ~20%.