Job Description
One of our large pharmaceutical clients is looking to hire a Sr. Quality Lab Specialist to join their External Quality organization supporting a CMO partnership in Gaithersburg MD. This individual will be primarily responsible for oversight across QC laboratories within cell and gene therapy. We are looking for someone experienced within the field, preferably working with CAR-T methods.
Responsibilities will include:
-Ongoing quality oversight (on-site and/or remote) of the site and process qualification activities, including but not limited to laboratory release and in-process testing, engineering runs, and clinical/commercial cell therapy product manufacturing
-Provide Person-in-Plant quality oversight for day-to-day laboratory activities as well as production/qualification activities, including deviation and CAPA review, escalation of critical issues, batch review and release as well as change control management as needed
-Support of quality performance monitoring and proactive identification of risks
-Communication (as needed) of nonconforming, out of trend, or out of specification results
-Support regulatory submissions and influence internal and external functions (Operations, Planning, Technical Operations, etc) to continuously enhance quality performance as needed
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/.
Required Skills & Experience
-Bachelor degree in Scientific field
-Minimum 3-5 years of experience working with GMP pharmaceutical manufacturing within cell and gene therapy
-Flow Cytometry experience and cell counting within a QC laboratory
-Expertise handing review and approval of batch record review, RFFP activities, CAPAs, Change Controls, deviations, quality product complaints, and risk assessments
-Previous experience with CMO/CDMO relationships -Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Nice to Have Skills & Experience
-CAR T experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.