Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the ultimate goal of inducing long-term responses in patients with solid tumors. Reporting to the Head of Quality Assurance, the Associate Director, Quality Operations and Systems, is a hybrid role that will be pivotal in supporting ongoing manufacturing and quality operations. Responsibilities include conducting timely batch record reviews, manufacturing deviations reviews, Out of Specification reviews, and collaborating with the CDMO’s in ensuring timely disposition of drug product batches. Additionally, this position will support in managing internal quality system processes which includes the following: document control, training, change controls, deviations, CAPA, and product complaints to ensure compliance with internal policies and procedures.

• Conduct timely and thorough batch record reviews to ensure compliance with regulatory requirements and internal procedures.
• Review manufacturing related deviations and proposed Corrective Actions from CDMO.
• Review Out of Specification (OOS) to determine and resolve issues related to product quality.
• Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to ensure timely disposition of drug product batches.
• Support the Senior Director of Quality in managing internal quality system processes, including document control, training, change controls, deviations, CAPA, and product complaints.
• Act as a Subject Matter Expert (SME) for document control and other quality system processes.
• Maintain current knowledge of industry trends and best practices in quality management.

Education and Experience:

• A Bachelor of Science in a scientific discipline is required and a minimum of 10 years of experience in Quality.
• Experience with batch record review and batch disposition.
• Experience in managing document control, deviation, and CAPA.
• Cell and Gene therapy experience is a plus.
• Preferred experience with outsourced manufacturing.

The successful candidate will have the following attributes:

• Proven track record of building relationships and influencing across disciplines and all levels.
• Strong interpersonal skills to effectively communicate with team, peers, Management, and external contacts.

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