QC Scientist I, Cell Therapy — Method Validation

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

Benefits offered by this job

401K employer match

Tuition Reimbursement

Flexible work schedules

Paid holidays

Job summary

Cellipont Bioservices is seeking a QC Scientist I to support the quality control department with analytical method qualification/validation for cell therapy products in a GMP setting. You will independently execute complex laboratory work and prepare technical documentation, ensuring timely and cost-effective results.

The role requires cross-functional collaboration with QA, AD, manufacturing, and PD teams, plus hands-on experience in flow cytometry, cell-based assays, and GMP environments.

Qualifications

• B.S. in Biology, Biochemistry, Biotechnology, Immunology, Microbiology or related field; Master’s degree preferred.
• Minimum 4 years in biotechnology, pharmaceutical, or cell therapy with analytical method qualification/validation experience.
• Hands-on mammalian cell culture and aseptic technique in GMP environment.
• Experience with flow cytometry, potency, viability, and molecular assays is preferred.
• Strong self-starter with ability to meet client deadlines under minimal supervision.

Responsibilities

• Execute analytical method qualification and validation studies for release, stability, characterization and in-process testing in GMP.
• Independently perform cell-based assays including potency, flow cytometry, viability, proliferation and cytotoxicity.
• Support transfer of commercial methods and method validation into QC per regulatory requirements.
• Generate and document data following GMP, GDP, ALCOA+ requirements.
• Present findings and assist in preparing technical reports and client presentations.

Skills

Flow cytometry

Mammalian cell culture

Analytical method validation

qPCR / PCR techniques

ELISA assays

GMP/GLP knowledge

Education

B.S. in Biology or related science

Master's preferred

Tools

Cell culture techniques

Analytical instrumentation

Job description

Cellipont Bioservices is seeking a QC Scientist I to support the quality control department with analytical method qualification/validation for cell therapy products in a GMP setting. You will independently execute complex laboratory work and prepare technical documentation, ensuring timely and cost-effective results.

The role requires cross-functional collaboration with QA, AD, manufacturing, and PD teams, plus hands-on experience in flow cytometry, cell-based assays, and GMP environments.