QC Scientist I — GMP Analytics & Validation (Cell Therapy)

Cellipont Bioservices; The Woodlands (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K employer match

Tuition Reimbursement

Employee Referral Bonuses

Flexible work schedules and PTO

Job summary

Cellipont Bioservices seeks a QC Scientist I to join our fast-paced quality control team. You will independently execute complex analytical work focused on method qualification and validation within a GMP environment, prepare technical documentation, and support QC investigations.

Strong cross-functional collaboration and leadership skills are essential as you drive timely, cost-effective testing to ensure client satisfaction.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Immunology, Microbiology, or related scientific discipline; Master's Degree preferred.
• 4+ years of experience in biotechnology, pharmaceutical or cell therapy; analytical method qualification/validation is a must.
• Hands-on experience with mammalian cell culture and aseptic techniques in a laboratory and/or GMP environment.
• Experience performing analytical methods including flow cytometry, cell-based potency, viability, proliferation, cytotoxicity, ELISA or molecular assays preferred.
• 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 method transfers/qualifications/validations is a plus.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.

Responsibilities

• Execute analytical method qualification and validation studies supporting release, stability, characterization and in process testing of cell therapy products in a GMP environment.
• Independently perform cell-based assays, including potency, flow cytometry, viability, proliferation, cytotoxicity, ELISA, and molecular PCR testing methods, among others.
• Support transfer of commercial methods and method validation into QC in compliance with regulatory requirements.
• Generate, review, and document analytical data following GMP, GDP, ALCOA+, and regulatory compliance requirements.
• Present experimental findings and support preparation of technical reports and presentations to clients.
• Provide technical expertise on bioassay, flow cytometry and/or molecular biology methods in support of QC lab investigations, to identify root cause and provide corrective and preventative actions, if needed.
• Prepare and revise method qualification/validation protocols, technical reports, SOPs, and laboratory documentation supporting analytical method lifecycle management.
• Evaluate assay performance characteristics including accuracy, precision, specificity, robustness, and suitability for intended analytical applications.
• Collaborate with QA, Analytical Development (AD), Manufacturing and Process Development (PD) teams to support compliant analytical testing programs.
• 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

Mammalian cell culture

Flow cytometry

Cell-based potency assays

Analytical method qualification/valid

Molecular biology methods

ELISA

PCR

GMP knowledge

Strong communication

Education

Bachelor's degree in Biology/ Biochemistry/ Biotechnology/ Immunology/ Microbiology or related field

Master's degree preferred

Job description

Cellipont Bioservices seeks a QC Scientist I to join our fast-paced quality control team. You will independently execute complex analytical work focused on method qualification and validation within a GMP environment, prepare technical documentation, and support QC investigations.

Strong cross-functional collaboration and leadership skills are essential as you drive timely, cost-effective testing to ensure client satisfaction.