QC Scientist, I - Method Validation(W)

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 is growing, and we are looking for a QC Scientist I, who believes in the potential of bridging clients discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QC Scientist I works in a fast-paced environment supporting the quality control department cell therapy analytical method qualifications and validations. The QC Scientist I will be responsible for independent execution of complex laboratory/experiment work with a high degree of technical proficiency focused on method qualification and/or validation within a GMP environment, QC document preparation and revision (SOPs/Protocols/Reports), as well as technical support for QC lab investigations. The QC Scientist I is also responsible for ensuring all activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction. This role will require the individual to demonstrate strong ability to work cross-functionally and possess strong leadership skills.

The Role

• 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.

The Candidate

• B.S. in Biology, Biochemistry, Biotechnology, Immunology, Microbiology, or related scientific discipline, or Master's Degree preferred
• Minimum 4 years of experience in biotechnology, pharmaceutical or cell therapy experience required. Previous experiment 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.

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!