The Associate Director/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 Associate Director/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 travelup to 25%.
Excellent interpersonal and communication skills.
Strong computer skills, including all MS Office applications and MS Project