Research Associate

A Pharmaceutical Company is seeking a Research Associate in Frederick, MD.

Role Description

This role will provide process engineering and analytical support for commercial manufacturing of cell therapy. Working cross functionally with quality, operations, material management, facility and engineering functions, the role is expected to provide technical input for product/process response and investigations, technology implementation, technology transfers, process validation and regulatory filings.

• Execute scientific laboratory studies to support process/product understanding and continuous improvement projects

• Execute analytical testing of cell therapy products – flow cytometry, ELISA and PCR assays.

• Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench

• Provide technical input to the execution of process validation and comparability campaigns.

• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing

• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.

• Participate and report to a cross-functional team to advance production activities.

• Participate in Operational Excellence activities within Tier Structure.

• Participate continuous improvement projects supporting commercial manufacturing site

• Ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.

• Support technology transfers of launch and commercial cell therapy products

• Effectively & efficiently communicate manufacturing process performance internally.

• Support the implementation of automation and IT infrastructure projects

• Assist in writing technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation)

Skills & Requirements

• Bachelors Degree in Biochemical Engineering, Tumor Immunology, Biotechnology or Life Sciences.

• Basic understanding in Bioprocessing, Cell Culture and Biochemistry.

• Knowledge of ELISA and/or PCR testing

• Knowledge in flow cytometry and data analysis (FACSDiva, FlowJo, GraphPad Prism, Excel) is a plus

• Ability to think critically, demonstrate troubleshooting and problem-solving skills

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Previous experience with other technologies is a plus

• Experience with the use of Microsoft word, Excel, Power Point, Smartsheet, Prism, JMP, and other data analysis applications

• Highly collaborative with excellent interpersonal, verbal and written communication skills

• Ability to think critically with demonstrated problem-solving and troubleshooting skills

• Comfortable working in a fast-paced company environment with minimal direction and able to adjust workload/assignments based upon changing priorities

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description