Quality Control Manager

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Job description

About Kiromic BioPharma, Inc.



Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and our proprietary neural network platform with a therapeutic focus on immuno-oncology. As we journey to become the leader in immuno-oncology, target discovery and gene editing, we are developing highly effective and safe tumor-specific cancer engineered immunotherapies to face and defeat multiple cancer types. We are focused on extending the benefits of immunotherapy by leveraging DIAMOND AI (Kiromic Diamond Artificial Intelligence), that is a multi-purpose computational platform that can identify new cancer immunological targets for T-Cells and B-Cells.

Our mission is to discover, create and safely deliver the next generation of immunotherapy products that help patients conquer their diseases. We want to hire capable and forward- thinking individuals to become part of an extremely talented team whose goal is to save lives. We need people like you to help accomplish our goals. Come join us!

Quality Control Manager

Objective

Lead the company's Quality Control team that supports incoming materials release, manufacturing support, final product release testing, stability testing, and product development sample analysis. Lead laboratory process, scheduling, and testing optimization projects using lean/process excellence tools.

Responsibilities

•Lead incoming, in-process, and finished product QC team; responsible for development, coaching and cGMP training of QC personnel.

•Improves or sustains lean initiatives for quality, cost reduction, operational performance, and customer satisfaction.

•Champion of Continuous Improvement (CI) practices for the function and continues to promote and embed CI practices within the organization.

•Drives improvement in Quality Control processes by monitoring current systems and developing/managing internal performance of the QC function.

•Manages instrument capacity and resources to support daily production, trouble shooting, and validation needs. Collaborates with other departments to promote schedule attainment and problem resolution.

•Coordinates with supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods for distribution.

•Manages non-conformance events by conducting timely root cause investigations and implementing effective corrective actions.

•Oversees the testing and trending of the environmental monitoring program for operations and provides periodic reports.

•Implements and maintains cGMP (current Good Manufacturing Practices) standards, regulatory requirements with respect to the QC function. Represents the QC Lab during internal and external audits. Assigns projects to appropriate personnel and monitors progress and completion. Provides guidance to team members to achieve goals in accordance with established policies.

•Provides QC Team with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress.

•Adheres to all relevant laboratory safety rules / requirements for working in the laboratory as well as those specified for chemicals / reagents and equipment used for testing.

Qualifications

•Bachelor's Degree required, Master's Degree preferred (Chemistry or related field).

•Minimum seven years; four in a laboratory management role.

•Laboratory Skills: understanding of analytical chemistry principles and application of test methods in a cGMP environment, including wet chemistry / FTIR / HPLC / GC / KF Titration

•Six sigma / Lean training preferred.

•Demonstrated track record of optimizing laboratory cycle time performance, laboratory schedule management and personnel development.

•Highly skilled in analyzing cause and problem solving.

•Generates alternatives, creates relevant options for addressing complex

problems/opportunities and achieving desired outcomes.

•Quality Compliance / Good Lab Practice Experience.

•Awareness of the importance and data review.

•Ability to effectively present information.

•Effectively communicate and respond to questions from groups of managers, clients, or customers.