Senior Operational Quality Assurance Specialist

Immatics•Houston, TX

13d•Onsite

About The Position

J oin Immatics and s hape the f uture of c ancer i mmunotherapy ; 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 patient s globally . We ar e seek ing a Senior Operational Quality Assurance Specialist to support our Operational Quality Assurance & Systems team. The Senio r Opera tional Quality Assurance Specialist will perform internal audits of manufacturing/CMC procedures; track and m aintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release of I mmatic”s commercial and clinical products.

Requirements

Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field. A higher degree is preferred.
Extensive experience (4+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch release
At least 4+ years of Biotechnology and/or pharmaceutical industry experience is .
Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.
In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.
Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.
Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.
Ability to make sound decisions and approach problems with curiosity and open-mindedness
High degree of independent working, analytical reasoning, and the ability to communicate effectively
Careful editing and documenting of results
Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence
Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills
Ability to effectively collaborate with members from other departments
Legal eligibility to work in the United States is .

Responsibilities

Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.
Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.
Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.
Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.
Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations.
Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.
Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.
Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.
Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.
Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.
Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assurance

Benefits

Comprehensive Benefits : Competitive rates for Health, Dental, and Vision Insurance
4 weeks of P aid 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, up to 100K ( club together)
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company mat ch… 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 employmen t , 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
P artially 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 .
Professional Growth : Opportunities to work with leading experts in the field of T-cell immunotherapy.
Company provided learning and development opportunities
Fast paced, high demand collaborative and dynamic environment.