QC Lead Analyst

Cellipont; Research Forest (TX); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

401K strong employer match

Tuition Reimbursement

Flexible work schedules

PTO and holidays

Job summary

Cellipont Bioservices is seeking a QC Lead Analyst to join our fast-paced team in Texas. This role supports QC for manufacturing cell therapies, including routine testing, method transfer, validation, and deviation investigations.

The ideal candidate will lead quality control activities, author procedures, and mentor analysts in a highly regulated environment. The QC Lead Analyst will ensure timely, cost-effective execution of testing, manage QC equipment, and collaborate cross-functionally with

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.
• Hands-on experience with analytical methods including ELISAs, flow cytometry, and PCR.
• Experience with analytical method transfers/qualifications/validations and cGMP compliance.
• Excellent oral and written communication skills.

Responsibilities

• Perform routine and in-process testing for cell therapies and raw materials per SOPs.
• Support for method transfers/qualification/validation and routine testing.
• Author, review, and/or approve SOPs, test methods, and material specifications.
• Set up and operate QC equipment and coordinate maintenance.
• Mentor new staff and deliver training on assays per cGMP requirements.

Skills

ELISAs

Cell counting

Flow cytometry

Cell culture

PCR

Communication skills

Education

B.S in Life Sciences

A.S in Life Sciences

Job description

Job Summary

Cellipont Bioservices is growing, and we are looking for a QC Lead Analyst, who believes in the potential of bridging client's 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 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 QC Lead Analyst is also responsible for ensuring all activities are executed timely and cost-effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

The Role

• 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.

The Candidate

• 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 of 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!"