Job Description This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the CMO manufacturing organization in the following activities: -Manufacturing Support Operations -- Supporting CMO operators in manufacturing execution activities. -Support in technical writing for investigations / deviations and change controls. -Support in the execution and implementation of CAPAs. -Support in technical writing for batch records, SOPs, and other documents as needed. -Support in material ordering and ensuring sufficient supply of raw materials / process consumables. -Support in data transcription and analysis for manufacturing in process and release data. This position will be responsible for working with the contract manufacturing organization to drive improvements, oversee and support in manufacturing operations, ensure collaboration and communication, and execute tasks such as manufacturing investigations, change controls, batch record revisions, continuous improvement efforts and corrective and preventative actions. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements -Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing. -Minimum 5 years' experience in pharmaceutical manufacturing within cell & gene therapy -Minimum 5 years of experience performing QA responsibilities including batch record review, batch disposition, material release, and QA on the floor activities -Expertise in technical writing for quality events -Strong background Root Cause Analysis in a Pharmaceutical environment -Previous experience working with CMOs directly or indirectly -Experience working within CAR T null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.