Director of Process Engineering

Director, Process EngineeringLocation- Near San Francisco, CA (Relo Available)Check out www.scientificsearch.com for all of our openingsOverviewThe Director, Process Engineering will be responsible for process transfer, troubleshooting manufacturing issues, scaling up biopharmaceutical manufacturing processes, process characterization and process & equipment validation activities. The Director will also support routine drug substance manufacturing at Contract Manufacturing Organizations through batch data analysis, change control assessments, and deviation/investigation resolution.

Principle Responsibilities And Duties

• Provide technical oversight of routine drug substance manufacturing including, but not limited to, batch data analysis, change control assessment, and deviation resolution.
• Assist in the development of manufacturing documentation such as process descriptions, batch records and SOPs.
• Support feasibility assessments of additional manufacturing projects and partners for capabilities such as automation, equipment, GMP facility, process enhancement, and general requirements for scale-up and manufacturing
• Work in collaboration with manufacturing partners to define process requirements to meet production needs
• Use design of experiments techniques and basic statistical methods to analyze data and communicate results, conclusions, and recommendations.
• Monitor and communicate task status for project/program success.
• Participate in product and process FMEAs and related risk management processes.
• Potential travel to manufacturing sites (ex-US)

Experience, Education, Training, Traits

• BS degree in Chemical / Manufacturing Engineering or equivalent experience. MS/PhD is preferred
• Minimum 7+ years of experience in biotech/pharmaceutical industry required.
• Experience working with Contract Manufacturing Organizations (CMOs)
• Experience in process development and scale up through process validation and technology transfer including CMC preparation for regulatory filings
• Experience in support of routine drug substance manufacturing
• Detailed knowledge of cGMP requirements and application
• Proven ability to work collaboratively with all levels to meet project deliverables
• Must operate with a high degree of autonomy and professionalism
• Must be innovative, technical, resourceful and well organized
• Must communicate in a timely and accurate manner to ensure project participants are fully informed of project status, action items and deliverables
• Demonstrated ability to be flexible and maintain a professional attitude when priorities change
• Demonstrated ability to work in a fast paced, start-up environment
• Ability to travel up to 25%.
• Excellent interpersonal and communication skills.
• Strong computer skills, including all MS Office applications and MS Project

For immediate consideration, email paul@scientificsearch.com