QC Lead Analyst - Cell Therapy | cGMP, Training & Growth

Cellipont Bioservices; Silver Spring (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Opportunities for career growth within

Defined career path and annual review

Cross-functional exposure

Robust health & wellness benefits (pet

401K strong employer match

Tuition Reimbursement

Employee Referral Bonuses

Flexible work schedules and PTO

Cutting-edge cell therapy experience

Job summary

Cellipont Bioservices in Silver Spring, MD is seeking a QC Lead Analyst who will perform routine and in-process testing for cell therapies and raw materials, ensure compliance, support method transfers and validations, and author SOPs.

The candidate has a Life Sciences degree with relevant experience, hands-on skills in ELISAs, flow cytometry, cell culture and PCR, and strong cGMP knowledge. Excellent communication and training abilities are required.

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 ELISAs, cell counting, flow cytometry, cell culture, and/or PCR (qPCR or ddPCR).
• Hands-on experience with analytical method transfers/qualifications/validations.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.

Responsibilities

• Perform routine and in-process testing for cell therapies as well as raw materials, per departmental SOPs, as required.
• Apply technical knowledge and abilities 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 the day-to-day operations or testing.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Maintains QC laboratory and inventory.
• Assists 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.
• Assists in deviation and OOS investigations, and compiles data/information related to internal investigations as required.
• Responsible for 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.

Skills

ELISAs

cell counting

flow cytometry

cell culture

PCR (qPCR or ddPCR)

Education

B.S in Life Sciences

A.S. in Life Sciences

Job description

Cellipont Bioservices in Silver Spring, MD is seeking a QC Lead Analyst who will perform routine and in-process testing for cell therapies and raw materials, ensure compliance, support method transfers and validations, and author SOPs.

The candidate has a Life Sciences degree with relevant experience, hands-on skills in ELISAs, flow cytometry, cell culture and PCR, and strong cGMP knowledge. Excellent communication and training abilities are required.