Senior Quality Control Analyst
Immatics US, Inc. is a highly innovative biopharmaceutical company based in Houston, TX (USA) created through a partnership of MD Anderson Cancer Center with of Immatics Biotechnologies, headquartered in Germany. Our goal is to deliver adoptive cellular immunotherapies directed against novel cancer targets in indications with highly unmet medical need. Immatics is the globally leading biopharmaceutical company in the development of cancer immunotherpaies based on proprietary pMHC Targets and T-cell Receptors building a broad proprietary clinical pipeline as well as partnered pipelines with leaders in the field such as Amgen, Roche and Genmab.
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 so-called solid 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 based in Life Science Plaza in the Texas Medical Center in Houston (TX) with a significant 25,000 sq.ft. R&D and office infrastructure. Immatics US has a team of approximately sixty 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 passion for pioneering therapies and scientific innovation. We offer a competitive salary based on experience, and a comprehensive benefits package and a company culture based on people believing in taking responsibility and working together to deliver the best outcomes.
This position helps to foster a collaboration of analysts in the development, validation, and routine testing of product through the performance of microbiological, molecular/cell biological, and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support manufacturing.
- Execute bioanalytical methods
- Extract, compile, and analyze data.
- Data logging reporting and notebook upkeep.
- Identify and execute process improvements and technology optimization.
- Lead instrument calibration and preventive maintenance program.
- Identify opportunities for process improvement.
- Author or implement changes to controlled documents (e.g. specifications, methods, SOPs, etc.) and processes.
- Conduct all activities consistent with GMPs, regulatory filings, and written procedures
- Develop and validate analytical test methods.
- Perform instrument qualification/software validation.
- Conduct quality control release testing for raw materials, in-process materials, components, and finished products in accordance with cGMP regulations, regulatory filings, and approved procedures
- Review and approve in-process quality control data, change controls, deviations and test results for timely disposition of products for human clinical use.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- Bachelor’s or Master’s degree in a science related field.
- Five (5) years in a cGMP regulated Biologics or Pharmaceutical environment.
- Advanced skills with analytical equipment.
- Strong working knowledge of industry regulations.
- Proficiency in the application of QC principles, concepts, industry practices and standards.
- Experience in GMP bioassay testing, assay validation.
- Understanding of regulated work and compliance.
- Proficiency with data analysis
Other Skills and Abilities
self-directed and can work with limited direction in the dast-paced environment
Ability to work independently and manage projects with aggressice timelines
Strong analytical, technical writing, verbal communication and interpersonal skills
Very detail oriented
TO APPLY, PLEASE FORWARD RESUME TO HR-US@immatics.com