Job Description

JoinImmaticsandshape thefuture ofcancerimmunotherapy; one patient at atime!

Immaticsis 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. Ourcutting-edgescience and robust clinical pipeline form the broadest PRAMEfranchise with the most PRAMEindications and modalities, spanning TCR T-cell therapies and TCRbispecifics

Why Join Us?

• Innovative Environment:Help topioneeradvancementsin cancer immunotherapy.

• Collaborative Culture:Be part of a diverse team dedicated to your professionalgrowth.

• Global Impact:Contribute to therapies thatmakealasting impactonpatientsglobally

Weare seeking aSenior Operational Quality AssuranceSpecialist tosupport ourOperational Quality Assurance & Systemsteam.The Senior Operational Quality Assurance Specialistwillperform internal audits of manufacturing/CMC procedures; track andmaintainstandard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release ofImmatic”scommercial and clinical products.

FLSA Classification Hourly, Non-Exempt 
Schedule230PM –1100 PM; Monday to Friday; On-site 
Reports toAssociate Operational Quality Assurance Manager
Location 13203Murphy Road Suite 100 Stafford, TX 77477 

WhatYou’llDo:

AsaSenior Operational Quality Assurance Specialist,you will play a key role in supporting ourquality assurance team 

• 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.

• Ensureappropriate correctiveand preventive actions are implemented foridentifiedquality issues and deviations.

• Maintain and update batch release procedures, protocols, and documentationin accordance withcurrent 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.

• Identifyopportunities 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

RequiredExperienceandEducation

• Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, ora relatedfield. 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 isrequired

• 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.

Competencies

• 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 witha high levelof individual responsibility, enthusiasm, and strong social skills

• Ability to effectively collaborate with members from other departments

Work Environment: 

This is a sedentary position in a typical office environment (at least 10% of working hours) and/or clinical lab environment (~90% of working hours). There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners,computersand other office equipment. Ability to sit, talk, walk,hearand communicate verbally and in writing isrequired Occasional lifting of objects up to 25lbsis expected

Travel required:0%.

Physical demands:

• Communicating Verbally– expressing or exchanging ideasby means ofthe spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately,loudlyor quickly.

• Hearing– the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.

• Keyboarding– entering data or text into a computer or other machine by means ofa keyboard.Devices include a traditional keyboard, 10key-pad, touchscreensand others.

• Lifting- raising or lowering an object (up to 25lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or armsbutmay occur on the shoulder.

• Near Visual Acuity– clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

• Pushing- Exerting force upon an object so that the object moves away from the object.

• Pulling- Exerting force upon an object so that the object moves toward the force.

• Sitting– remainingin a sitting position for at least 50% of the time.

• Standing/Walking- remain on one's feet in an upright position at a workstation.

• Stooping– occasional bendingthe body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Work authorization/security clearancerequirements 

Legal eligibility to work in the United States isrequiredImmaticsparticipates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment  

Affirmative Action/EEO statement  

Immaticsis an equalopportunityemployer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.

What do we offer? 

AtImmatics, we believe in investing in our team’s health,safetyand well-beingHere’swhat you can expectif youjoinImmatics

Comprehensive Benefits 

• Competitive rates forHealth, Dental, and Vision Insurance

• 4 weeks ofPaid Timeoff, granted up front each year and prorated for firstand lastyear ofemployment.

• Sick Time Off–56 hours

• 12Paid Holidays

• 100%Employer-Paid Life Insurance up toat 1x annual salary,up to100K( clubtogether)

• 100%EmployerPaidShort- and Long-Term Disability Coverage 

• 401(k) with ImmediateEligibility &company match…

• You are eligible for 401(k) plan participation as of your first paycheck.

• The company will match100% of your contributions upto3% of yourbase salaryfor the first two yearsof employment, 4% foryears 2-3 of employment, and up to5%of your salaryfrom the fourth year onward of continued employment.

• PartiallypaidParentalLeave for eligible employees.(3 weeks)

• Additionalvoluntary employee paidcoveragesincluding Accident, Hospital Indemnity, and Critical Illness Employee PaidIdentity 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,highdemandcollaborative and dynamic environment.