Senior Quality Control Analyst

Immatics•Houston, TX

2d•Onsite

About The Position

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Senior Quality Control Analyst to join our Global Quality Operations team. In this role, the Senior Quality Control Analyst will be responsible for performing bioanalytical, cell-based, and molecular assays to support product release and stability testing within the Quality Control laboratory. The position will also play a key role in method transfer, qualification, and validation activities. FLSA Classification: Salary, Exempt Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site Reports to: Quality Control Manager Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

Requirements

BA or BS in any science-related field
Minimum five (5) years experience in a regulated laboratory environment
MS degree or specialized skill set may substitute for 3 years
Experience as a QC personnel in a related field.
Experience in aseptic technique, cell culture and either flow cytometry or cell-based assays.
Legal eligibility to work in the United States is required.

Nice To Haves

MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering
Minimum five (5) years experience in a regulated laboratory environment
Laboratory skills include a few of the following: visual inspection, flow cytometry, molecular and cell-based assays.
Demonstrate technical competence and knowledge in method transfer and assay qualification/validation activities
Excellent technical writing and troubleshooting/investigational skills.
Demonstrate knowledge of cGMP/ICH/EU regulations and requirements.
Experience writing GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.
Experience with LIMS and statistical software is a plus
Initiative
Problem Solving
Very detail oriented
Strong analytical
Technical writing, verbal communication, and interpersonal skills
Ability to work Independently and manage multiple projects with aggressive timelines

Responsibilities

Conduct Tests and Analyze Results: Perform routine and non-routine testing on products and materials to verify compliance with established standards.
Collaboration: Manage, in collaboration with other team members, purchasing, receiving, formulating, testing, release of materials and reagents, equipment and assay qualifications and validation.
Quality Records: Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.
Documentation: Author and conduct periodic review of procedures. Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures. Maintain data integrity and logs for equipment.
Data Analysis: Ability to analyze complex data sets and interpret results accurately. Able to identity trend and deviations, and take initiative to troubleshoot issues
Manage Laboratory Equipment: Perform and oversee the maintenance and calibration of laboratory equipment.
Ensure Compliance: Involved in the creation of systems used in quality control to maintain compliance with regulations.
Safety: Always demonstrate good safety practices and promote safety awareness.
Train and support junior analysts.
Transport controlled documents, QA-released QC materials and human biological samples.
Assist with group tasks scheduling
Maintain knowledge of internal procedures and current regulatory requirements

Benefits

Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance up to at 1x annual salary
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid Parental Leave for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness
Employee Paid Identity Theft Protection and Pet Insurance.