Senior Scientist – Manufacturing Science

Role Summary

Senior Scientist – Manufacturing Science responsible for technical support to ensure reliable and compliant manufacture of the API External Manufacturing portfolio, including raw materials, intermediates, enzymes, and bulk drug substances. Executes technical projects to improve and optimize process control, yield, purity, and productivity. Capable of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting.

Responsibilities

• Understand the scientific principles for manufacturing intermediates and bulk drug substances, including interaction of chemistry and equipment.
• 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.
• Document the state of validation (process and cleaning) with data that evaluate manufacturing process capability.
• Ensure accurate instruction sets (tickets and procedures) and PFD describe the process and control strategy for discrete manufacturing steps.
• Provide support to internal and joint process teams and to global/local PLOT teams.
• Independently set up and execute various chemical reactions.
• Design experiments with clear objectives and analyze data with proper documentation.
• Adhere to good laboratory practices and CHP requirements.
• Write technical reports and documents.

Qualifications

• Required: 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Preferred: Demonstrated knowledge in small molecule API Manufacturing; familiarity with cGMP 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.

Skills

• Strong analytical and data interpretation skills
• Technical writing and documentation
• Experiment design and execution
• Process understanding and control strategy development

Education

• Bachelors or equivalent in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry, or related field

Additional Requirements

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