Sr. Engineer or Sr. Scientist, API Development

Role Summary

Responsible for cell culture process development activities associated with the advancement of biologic assets from pre-clinical through commercial phases. This includes laboratory experimentation and collaboration with external partners for process development and clinical or commercial manufacturing. Strong scientific knowledge is required to enable cell culture process parameter establishment, optimization, and characterization to ensure robust delivery of the pipeline. The position also requires regulatory awareness, quality and cGMP knowledge, and an ability to build relationships with cross-functional and external partners. May train other scientists, engineers and/or team members.

Responsibilities

• Apply scientific or engineering principles with increasing complexity to lifecycle responsibilities from cell line development to cell culture process development including process definition, optimization, characterization, and validation
• May lead cell culture process scale-up and technology transfer initiatives identifying and mitigating risks
• Supports project planning and advancement efforts. Participates in cross-functional teams
• Maintains accountability for assigned deliverables including production plans for development projects
• May contribute to risk assessments to support project advancement
• Independently designs, plans, and executes cell culture activities towards the goals of one or more development projects to support preclinical through commercial activities
• Ensures laboratory work is efficient, productive, and adheres to safe practices
• Independently identifies process challenges and leads necessary optimization activities including trouble-shooting experimentation
• Identifies, recommends, and evaluates new methods and techniques to improve product quality, manufacture consistency, or to achieve cost effectiveness
• Assists with managing contract manufacturing activities and may directly interact with contractors
• May provide input for select sections of CMC regulatory documentation and supporting work
• May train lower-level scientists and/or team members
• Build internal and external professional relationships
• Other duties as assigned

Qualifications

• BS/BA degree in chemical engineering, biochemical engineering, or similar engineering discipline AND 4+ years of relevant experience OR
• MS/MA degree in chemical engineering, biochemical engineering, or similar engineering discipline AND 3+ years of relevant experience OR
• PhD in chemical engineering, biochemical engineering, or similar engineering discipline AND 2+ years relevant experience; may include postdoc experience
• Experience with cell culture techniques in a process development environment including hands-on experience with various bioreactor models and bioreactor scales. Must be skilled in aseptic technique
• Strong knowledge in process optimization approaches and understanding of potential process risks
• Experience with high throughput cell culture development and familiarity with current technologies for improvement of cell productivity and product quality
• Knowledge of or experience with cell line development
• Manufacturing experience including with external partners
• Good understanding of cGMP and regulatory requirements
• Demonstration of cross-functional understanding related to drug development
• Strong knowledge of scientific or engineering principles, methods and techniques
• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
• Able to explain the process behind the data, implications of the results, and plan next steps
• Ability to build and manage internal and external working relationships
• Detail oriented
• Ability to work as part of a team. May train lower-level scientist or engineers
• Strong communication, problem-solving, analytical thinking skills
• Broader picture understanding of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Good project management and interpersonal skills

Education

• BS/BA in chemical/biochemical engineering or related field with 4+ years of experience, or
• MS/MA in chemical/biochemical engineering or related field with 3+ years of experience, or
• PhD in chemical/biochemical engineering or related field with 2+ years of relevant experience