Analytical Assay Development Manager

The Analytical Assay Development (AAD) Manager at Expression Manufacturing LLC (EMLLC) will typically have a graduate level degree (Ph.D., M.S.) in a related discipline (Biology, Molecular and Cellular Biology, Biochemistry, etc.). The Manager will report to the President, EMLLC. Key responsibilities are to oversee, manage, and lead all Analytical Assay development efforts and work collaboratively with Quality Control (QC) laboratory personnel to successfully transfer the assay into practice and train the technicians performing the assay. This work must be done consistent with required quality systems and compliant with Good Manufacturing Practice (GMP) and/or other regulatory guidelines. The position requires a strong technical background with good organizational leaderships qualities in order to work across teams and manage successful completion of key tasks in a timely manner. The AAD Manager may often be a member of cross functional teams organized and formed to address a specific concern or develop a new process or may even lead them.

Responsibilities:

• Develop, perform, and document analytical procedures with accuracy, consistency, and timeliness in accordance with current SOPs and regulations. 
• Develop new Standard Operating Procedures (SOPs) for new analytical assays being developed for company needs.
• Ensure that current SOPs for analytical assays meet the assay performance expectations.
• Research, write, and execute analytical assay validation protocols for assays to be performed at the company.
• Oversee, manage, and lead the Analytical Assay development team.
• Establish, perform, and document training of QC staff in areas requiring demonstrated competency for assay execution. 
• Oversee QC laboratory transfer of the assay into practice.
• As needed conduct regulated (GMP, Good Laboratory Practice, Good Clinical Practice) as well as non-regulated (Research & Development, Process Development, and Feasibility) assays.
• Working with Quality Assurance, implement and oversee laboratory compliance with regulatory expectations for the AAD and QC group.
• Work across teams to assist with and support GMP and Research & Development activities
• Remain current with advancements in the cell and gene therapy field and analytical testing.
• Adapt to rapidly changing organizational and business needs.
• Promote open communication among the team members. 

Education and Experience: 

• Preferred (Advanced degree (Ph.D.) in a related field with demonstrated expertise in PCR, ELISA, and Chromatography methodologies, M.S. degree with 2 years’ experience in either the AAD or QC laboratory) or B.S. with 5 years’ experience in either the AAD or QC laboratory. 
• Previous work experience in a GMP compliant Contract Development and Manufacturing Organization/Pharma operation is beneficial. 
• Proven record of successfully performing assay validations is preferred.