Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. Our goal is to deliver adoptive cellular immunotherapies for novel cancer targets in indications with highly unmet medical need. Immatics is the leading biopharmaceutical company in the development of cancer immunotherapeutics based on tumor-associated peptides (TUMAPs) that constitute the most relevant targets for all T-cell based immunotherapies.
Immatics US pipeline is based on adoptive cellular therapy (ACT). ACT has demonstrated dramatic clinical effects in melanoma and certain blood cancers. However, relevant and safe targets to translate these initial successes to other cancer types are critically lacking to the field. ACT has the potential to induce significant clinical benefits including rapid clinical responses and can potentially be developed up to FDA marketing approval within few years.
Immatics US is headquartered in Houston with a significant R&D infrastructure. Immatics US has a team of highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science. We offer a competitive salary based on experience, and a comprehensive benefits package.
Quality Control Manager (Exempt)
The Department of Quality Control (QC) at Immatics has an opportunity for a highly motivated and talented Senior Scientist. This role supports method introduction and compliance for the testing of raw materials for GMP use in manufacturing. Responsible for projects such as material risk assessments, method development, method validations and qualifications.
- Initiate and review documentation (change controls, specifications, protocols, reports, raw data packages, etc.) pertaining to release, stability, investigations, method transfers, method validation and reference standard characterization, etc.
- Develop, perform, document and report tests related to raw materials, in-process finished goods subassemblies, and assays/analytical methods, including investigation and providing corrective action plan for out-of-specification and/or non-conforming test results.
- Oversee QC related activities and provide regular stability updates to cross-functional teams and stability related investigations.
- Contribute to the development of QC methods, including flow cytometric methods.
- Key subject matter expert for procedure-based assay qualification, validation and technology transfer.
- Perform inspection and testing of raw materials and in-process finished goods.
- Document test results, complete test records, document observations and generate reports for raw material and in-process finished goods qualification testing.
- Assess new materials to determine test methods and validation/qualification requirements.
- Author and may approve technical documents, such as operating procedures, test methods, and reports.
- Supervise QC Analysts, including work assignments and performance management.
- Maintain records and QC laboratory environment to comply with cGMP, SOP and regulatory requirements.
- Serve as contact for other departments regarding QC related activities, quality issues, nonconformance investigations and root cause analysis.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- Master’s Degree or Ph.D. in Biochemistry/Molecular Biology/Immunology or related field with 4-6 years of relevant experience.
- Strong knowledge of flow cytometry, including method development and validation.
- Advanced knowledge of cGMP and industry standards pertaining to Quality Control raw material inspection, sampling, testing, and approval is essential to ensure compliance.
- Have strong observational and analytical skills to analyze experiments and draw conclusions from results.
- Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activities.
Other Skills and Abilities
- Ability to communicate effectively, both verbally and in writing.
- Ability to influence and advocate course of action of a research project.
- Comfortable working in a stringent environment performing routine scientific tasks.
- Well organized and has the ability to work effectively under pressure to meet deadlines and benchmarks.