QC Scientist Method Validation; W

Job Summary Cellipont Bioservices is growing, and we are looking for a QC Scientist I who believes in the potential of bridging client discoveries to patient cures and wants to challenge the status quo. The QC Scientist I works in a fast‑paced environment supporting the quality control department’s cell therapy analytical method qualifications and validations. The role requires independent execution of complex laboratory work with high technical proficiency focused on method qualification and/or validation within a GMP environment, QC document preparation and revision (SOPs/Protocols/Reports), and technical support for QC lab investigations.

The QC Scientist I must ensure all activities are executed timely and cost effectively to satisfy customer and stakeholder expectations, demonstrate strong cross‑functional collaboration, and possess strong leadership skills.

• 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.

• B.S. in Biology, Biochemistry, Biotechnology, Immunology, Microbiology, or related scientific discipline;
  Master’s Degree preferred.
• Minimum 4 years of experience in biotechnology, pharmaceutical or cell therapy; previous experience in 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.
• Technical background and expertise in flow cytometry is a plus.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.

• Opportunities for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross‑functional exposure to other areas within the organization.
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members.
• 401(k) 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.