QC Lead Analyst

Job Summary

Cellipont Bioservices is growing, and we are looking for a QC Lead Analyst who believes in the potential of bridging client discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QC Lead Analyst works in a fast‑paced environment supporting the quality control department of a CDMO for manufacturing cell therapies.

The role handles routine testing, assay transfer and validation, QC document preparation and revision, laboratory investigations, and laboratory setup and maintenance. The analyst ensures all activities are executed timely and cost‑effectively for customer and stakeholder satisfaction and demonstrates strong cross‑functional collaboration and leadership skills.

• Perform routine and in‑process testing for cell therapies and 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 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 with facility personnel.
• Anticipate and troubleshoot problems in the day‑to‑day operations or testing; communicate effectively with management regarding task completion, roadblocks, and needs.
• Maintain QC laboratory and inventory.
• Assist in training and mentoring new staff and become a qualified trainer on assigned assays, delivering training to analysts while documenting training per procedural and cGMP requirements.
• Assist in deviation and OOS investigations, compiling data and information related to internal investigations as required.
• Follow up with outside or third‑party testing labs regarding testing and turnaround 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.

• 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 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.

• 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 furry family members.
• 401(k) with strong employer match.
• Tuition reimbursement.
• Employee referral bonuses.
• Flexible work schedules and PTO based on role/level, increasing one 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!