Cellipont Bioservices
Overview
QC Lead Analyst role at Cellipont Bioservices. The QC Lead Analyst works in a fast-paced environment supporting the quality control department of a CDMO for manufacturing cell therapies. The QC Lead Analyst will be responsible for routine testing, assay transfer, and assay validation, QC document preparation and revision (SOPs/Protocols/Reports), laboratory investigations, and laboratory setup and maintenance. The role is focused on ensuring all activities are executed timely and cost-effectively to meet customer and stakeholder expectations, with strong cross-functional collaboration and leadership responsibilities. Responsibilities
Perform routine and in-process testing for cell therapies as well as raw materials, per departmental SOPs, as required. Apply technical knowledge to ensure all testing is performed in a compliant manner. Provide support for method transfers/qualification/validation and routine testing of in-process, final product, or stability samples. Author, review, and/or approve SOPs, test methods, material specifications, and other procedures required to operate a QC laboratory. Review data following applicable procedures and cGMP requirements. Set up and operate quality control equipment, including cell counters, centrifuges, and BSCs, and coordinate maintenance of this equipment with facility personnel. Anticipate and troubleshoot problems in day-to-day operations or testing. Communicate effectively with management regarding task completion, roadblocks, and needs. Maintain the QC laboratory and inventory. Assist in training and mentoring new staff. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Assist in deviation and OOS investigations, and compile data/information related to internal investigations as required. Follow up with outside or third-party testing labs regarding testing and turn-around times for results. Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Communicate effectively with cross-functional peers, department management, and other partners as needed. Qualifications
B.S. in Life Sciences with 3 years of direct industry experience or A.S. in Life Sciences with 5 years of direct industry experience. Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision. Hands-on experience with various analytical techniques, including ELISAs, cell counting, flow cytometry, cell culture, and/or PCR (qPCR or ddPCR). Hands-on experience with analytical method transfers/qualifications/validations. Hands-on experience with compendial method verifications. Hands-on experience with system management is a plus. Technical background and expertise in flow cytometry is a plus. Knowledge of cGMP/ICH/FDA regulations. Excellent oral and written communication skills. Position Benefits
Opportunities for career growth within an expanding team Defined career path and annual performance review & feedback process Cross-functional exposure to other areas within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members 401K strong employer match Tuition Reimbursement Employee Referral Bonuses Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays Gain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our family approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm Representatives: Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.
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QC Lead Analyst role at Cellipont Bioservices. The QC Lead Analyst works in a fast-paced environment supporting the quality control department of a CDMO for manufacturing cell therapies. The QC Lead Analyst will be responsible for routine testing, assay transfer, and assay validation, QC document preparation and revision (SOPs/Protocols/Reports), laboratory investigations, and laboratory setup and maintenance. The role is focused on ensuring all activities are executed timely and cost-effectively to meet customer and stakeholder expectations, with strong cross-functional collaboration and leadership responsibilities. Responsibilities
Perform routine and in-process testing for cell therapies as well as raw materials, per departmental SOPs, as required. Apply technical knowledge to ensure all testing is performed in a compliant manner. Provide support for method transfers/qualification/validation and routine testing of in-process, final product, or stability samples. Author, review, and/or approve SOPs, test methods, material specifications, and other procedures required to operate a QC laboratory. Review data following applicable procedures and cGMP requirements. Set up and operate quality control equipment, including cell counters, centrifuges, and BSCs, and coordinate maintenance of this equipment with facility personnel. Anticipate and troubleshoot problems in day-to-day operations or testing. Communicate effectively with management regarding task completion, roadblocks, and needs. Maintain the QC laboratory and inventory. Assist in training and mentoring new staff. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Assist in deviation and OOS investigations, and compile data/information related to internal investigations as required. Follow up with outside or third-party testing labs regarding testing and turn-around times for results. Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Communicate effectively with cross-functional peers, department management, and other partners as needed. Qualifications
B.S. in Life Sciences with 3 years of direct industry experience or A.S. in Life Sciences with 5 years of direct industry experience. Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision. Hands-on experience with various analytical techniques, including ELISAs, cell counting, flow cytometry, cell culture, and/or PCR (qPCR or ddPCR). Hands-on experience with analytical method transfers/qualifications/validations. Hands-on experience with compendial method verifications. Hands-on experience with system management is a plus. Technical background and expertise in flow cytometry is a plus. Knowledge of cGMP/ICH/FDA regulations. Excellent oral and written communication skills. Position Benefits
Opportunities for career growth within an expanding team Defined career path and annual performance review & feedback process Cross-functional exposure to other areas within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members 401K strong employer match Tuition Reimbursement Employee Referral Bonuses Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays Gain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our family approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm Representatives: Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.
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