Senior Associate, Quality Control, Analytical

ImmPACT-Bio is seeking a Senior Associate for the Quality Control (QC) Analytical Department to support routine QC activities for clinical and future commercial manufacturing at our new GMP cell therapy production facility in West Hills, CA.

This individual will perform laboratory testing utilizing techniques such as ELISA, flow cytometry, digital droplet PCR (ddPCR), functional assays, cell culture, and sterile technique to ensure compliance with quality, safety, and specification standards for drug substance and product release attributes.

This role involves conducting QC analytical testing to ensure products meet regulatory and quality standards, focusing on consistency and compliance for clinical use.

It includes maintaining accurate records, investigating discrepancies, and supporting method transfer activities. Responsibilities include laboratory maintenance, troubleshooting equipment, mentoring junior staff, and managing QC documentation.

The role involves leading change control activities, supporting regulatory audits, and identifying process improvements while collaborating with cross-functional teams.

This full-time position reports to the Analytical Manager of Quality Control.

Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.

Primary Responsibilities :

• Conduct QC analytical testing to support in-process evaluations, product release, and stability assessments. Ensures that products meet quality and compliance standards for clinical use, focusing on consistency and regulatory adherence.
• Maintain detailed and accurate records of testing procedures, data packet results, and other relevant documentation following Good Documentation Practices (GDP) standards.
• Investigate, resolve, and document discrepancies related to testing and analytical processes, and support subsequent investigations, deviations, out-of-specification (OOS) procedures, and Corrective and Preventative Action (CAPA) processes.
• Lead and participate in method transfer activities in collaboration with Analytical Development and Process Science for new or updated analytical testing procedures.

Responsibilities include conducting assay method training, generating and executing qualification protocols, facilitating internal QC cross-training, and managing the life cycle of approved test methods.

• Supports QC laboratory functions for equipment troubleshooting, laboratory maintenance, monitor of lab supplies, and management of sample inventory.
• Provide technical guidance, support training, and mentor junior analysts and other team members.
• Author, prepare and review QC documentation, including test reports, standard operating procedures, analytical methods, protocols, and certificates of analysis.
• Lead change control activities to oversee integration and modifications to systems, processes, products, and equipment.
• Assists with addressing questions during regulatory compliance audits and supports inspection related needs as required.
• Identify opportunities for process improvements and implement changes to enhance efficiency and accuracy for QC related methods, standard operating procedures, and protocols.
• Maintains strong interactions and cross functional support with associated functional departments (Quality Assurance, QC Microbiology, Manufacturing, MSAT, Analytical Development, Supply Chain, and Warehouse).

Qualifications :

• Bachelor's Degree in Sciences or related field and 8+ years’, MS with 6+ years, PhD with 3+ years, or HS with 10+ years' experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility or an AA Degree and 9+ years' experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Demonstrated knowledge and experience in laboratory techniques and platforms including but not limited to : flow cytometry, ELISA, ddPCR, cell culture, and functional cell-based assays.
• Experience with method transfer, qualification, and development.
• Knowledge of Quality Management Systems (QMS) and experience with change controls, deviations, CAPA, and OOS processes.
• Strong understanding of data analysis, interpretation, and presentation including use of software tools for statistical analysis.
• Familiarity with regulatory requirements (e.g. FDA, EMA, TGA) and ICH guidelines.
• Experience with regulatory audits and compliance inspections is a plus.
• Excellent written and verbal communication skills for preparing documentation, reports, and communicating with cross-functional teams.
• Strong attention to detail and accuracy in record-keeping and data analysis.
• Strong organizational skills and the ability to manage multiple tasks and priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
• Leadership and mentoring experience, as the role may involve training and guiding junior analysts.
• Proficiency in maintenance and troubleshooting of GMP laboratory equipment.
• Team player with good interpersonal skills.
• Includes other duties and responsibilities as assigned. Duties and responsibilities may be modified or changed at any time based on the needs of the business.

Worksite Location :

Onsite in West Hills, CA

Work Schedule :

Tuesday through Saturday or Sunday through Thursday

Travel Requirements :

Willingness to travel domestically or internationally up to 15% of the time

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