Engineer​/Scientist

Job Description

• Conducts lab and pilot plant experiments
• Generates and coordinates execution sampling protocols
• Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
• Leads and supports technology transfer (TT) across multiple unit operation
• Coordinates, plans, and executes manufacturing process validation runs
• Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
• Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.
• Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
• Interprets and utilizes new knowledge to promptly drive data-based decisions
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
• Other duties, as assigned

• Proficient knowledge in Design of Experience (DOE)
• Proficient knowledge in Statistical Process Control
• Effective communication, both written and oral
• Ability to effectively present information to others
• Proficient project management skills
• Advanced problem-solving skills
• Ability to provide feedback to others, including leaders
• Ability to develop effective working relationships internally and externally
• Ability to adapt communication style to differing audiences and advise others on difficult matters

• Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing)
• Master’s degree with 3 years of related work experience; or
• PhD with no prior experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience using risk management and RCA tools

• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance and manufacturing experience, including process development, validation, and transfer

• Ability to discern audible cues.

• Mid-Senior level

• Full-time

• Engineering and Information Technology