QC Lead Analyst

Cellipont Bioservices • The Woodlands, TX

2d

About The Position

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.

Requirements

• 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.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.

Nice To Haves

• Hands-on experience with system management is a plus.
• Technical background and expertise in flow cytometry is a plus.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level