Associate Engineer, Drug Substance

The Opportunity:

• Work closely with DS, Analytical Development-QC and Quality teams to enable large-scale commercial manufacturing readiness, through process development and optimization studies conducted according to the principles of quality by design (QbD), establish control strategy and process characterization studies using tools such as design of experiment (DOE) studies.

• Support demonstration that large-scale manufacturing of DS can be conducted safely by proactively identifying risks and developing mitigation strategies (e.g. using reaction calorimetry and principles of FMEA and HAZOP).

• Support the transition of manufacturing of drug substance from clinical-stage through Process Performance Qualification (PPQ) to commercial-stage, and support commercial-stage activities (e.g. Continuous Performance Verification, CDMO relationship, etc.).

• Support technology transfer, process familiarization, and manufacturing at CDMOs, including PIP as needed.

• Review protocols, manufacturing batch records, development and campaign reports for clinical-scale and commercial-scale manufacturing.

• Utilize internal AI platform(s) to improve workflows and efficiency, for both internal team and cross-functional benefit.

• Communicate effectively within cross functional project teams.

• Travel to CDMO for the oversight of development activities and manufacturing (up to approximately 25%).

Required Experience, Skills and Education:

• BS chemical engineering or related discipline with 0-3 years industrial experience, in small-molecule chemical / drug substance process research and development .

• Familiar with synthetic organic chemistry.

• Familiar with review, update and creation of Process Flow Diagrams (PFDs) and Process & Instrumentation Diagrams (P&IDs).

• Familiar with writing, reviewing and updating Master and Executed Batch Records (MBRs and EBRs).

• Fluent in use of Microsoft Office products (Excel, Power Point, Word, Visio).

• Knowledge of current ICH guidelines, cGMP guidelines, and relevant industry practices.

• Strong problem solving skills with sound technically driven decision-making ability.

• Effective written and verbal communication skills and interpersonal skillsAn innovative team-player with high energy for our dynamic company environment.

Preferred Skills:

• Experience using AI platform(s) to improve workflows and efficiency, especially for Engineering calculations.

• Previous experience in chemical/small molecule manufacturing campaigns.

• Previous experience with Process Safety evaluations.

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