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Quality Control Analytics Supervisor
2 months ago
Salary: Competitive
Role Summary:
The Quality Control Analytics Supervisor is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics Inc. This role encompasses various testing operations, including in-process assessments, final product evaluations, and stability analyses for both clinical and commercial batches. Candidates should possess hands-on expertise in at least two of the following areas: cell maintenance and counting (NC-200), cell-based potency assessments utilizing diverse immunoassays (such as ELISA), and/or identification and characterization assays through multi-color flow cytometry techniques. This position plays a crucial role in the establishment of QC Analytical release assays and other functions within a newly constructed facility dedicated to cell therapy products.
Key Responsibilities:
- Independently manage all laboratory operations with minimal oversight.
- Oversee the execution of laboratory activities, including release testing and maintenance tasks.
- Supervise the technical transfer, qualification, and validation of QC Analytical test methodologies for in-process materials, lot release, and stability as required.
- Conduct daily GMP QC laboratory testing at the facility.
- Draft, review, and approve SOPs, protocols, reports, specifications, and other QC documentation.
- Ensure timely data trending for all generated results.
- Lead investigations into out-of-specification test outcomes, implementing corrective actions and verifying their effectiveness.
- Support product stability initiatives, including the creation of stability protocols, execution of stability tests, and transfer of results to external QC.
- Guarantee that daily GMP QC laboratory testing is performed accurately and in compliance with relevant procedures, standards, and GMP regulations.
- Enhance technical skills through qualification on all QC analytical release assays.
- Act as a qualified trainer and technical reviewer for all QC analytical assays as necessary.
- Foster professional growth among QC Analytics team members.
- Build strong working relationships with internal and cross-functional teams.
- Assist in resolving technical issues related to GMP QC, collaborating with subject matter experts as needed.
- Maintain a high level of efficiency, producing quality and precise results in a dynamic environment.
- Support inspections by Health Authorities.
- Adhere to Iovance Biotherapeutics' core values, policies, and ethical standards.
- Comply with safety protocols and laboratory procedures as per company policy and OSHA regulations.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's degree in a relevant field (biological sciences or equivalent) or a comparable combination of education and experience.
- A minimum of six (6) years of experience in the biopharmaceutical sector within a QC capacity, with experience in cell therapy products being advantageous.
- Strong understanding and practical knowledge in at least one of the following: Cell-Based Potency Assays and supporting ELISA platforms and/or Multi-color flow cytometry for identification, characterization, and potency analysis.
- Comprehensive knowledge of biological drug development in relation to QC.
- Proficient in technical writing (e.g., test methods, SOPs, protocols).
- Detail-oriented with robust technical capabilities.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities effectively while maintaining high productivity.
- Demonstrated urgency and awareness of time-sensitive tasks.
- Adaptable and eager to tackle challenges.
- Proactive problem solver who identifies and addresses issues effectively.
Preferred Qualifications:
- Advanced degree in a relevant field (biological sciences or equivalent).
- Experience in supervising a team.
- Familiarity with cell and/or gene therapy products.
Physical and Mental Requirements:
- Ability to wear appropriate Personal Protective Equipment (PPE).
- Must meet requirements for and be able to wear a half-face respirator.
- Capable of standing and/or walking for 90% of a 10-hour workday, with occasional climbing.
- Able to perform activities involving bending, twisting, reaching, and repetitive motions.
- Must be able to lift and carry objects weighing up to 30 pounds.
Work Environment:
- This position involves working in both an office and a QC laboratory setting.
- Laboratory work may expose individuals to various chemical and biochemical substances.
- Potential exposure to noise, equipment hazards, and strong odors.
The responsibilities outlined in this document are intended to convey the general nature and level of work performed by individuals in this role. They are not exhaustive and may be subject to change at management's discretion.
Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal opportunity employer, we consider all employees and applicants without regard to race, color, religion, sex, pregnancy, national origin, age, disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other characteristic protected by applicable law.
