Manufacturing Associate I - Second Shift

Immatics•Houston, TX

9d•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. FLSA Classification: Non-exempt/Hourly Schedule: Monday-Friday (On-Site); 12:30pm -21:00pm; (40 hours/week); Weekends/holidays as needed Department: CMC-GMP Reports to: Associate Manager, CMC-GMP Supervisory responsibilities: No Location: Manufacturing personnel alternate between the current office and manufacturing locations. Weatherford - 13203 Murphy Rd. Stafford, TX 77477 UTHealth Science Center- 1941 East Rd, BBSB 6102 Houston, TX 77054 Position Summary/objective: The primary purpose of this position is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing. Essential functions: Knowledge of current cGMP. Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash. Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA. Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs. Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions. Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers. Ability to work productively and to participate in a highly creative and fast-paced environment. Secondary functions: Independently perform calculations to determine cell viability, dilutions, and cell concentrations. Completes all appropriate logs and trackers. Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility. Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria. Conducts activities to support study plans, and IQ/OQ/PQs. Provide input or feedback regarding change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed. Performs routine equipment maintenance and troubleshooting. Prepares and presents manufacturing summaries, as needed. Competencies: Independent Working- close supervision of all tasks. Communication- clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor). Problem Solving- ability to identify and communicate problems. Critical Thinking- basic reflection on standard processes; identification of basic need and room for improvement within own or narrow scope. Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities. Organizational & Prioritization Skills- basic organization skills required to structure own daily tasks according to predefined work packages, schedule and standard lab processes, prioritization in close interaction with supervisor. Coachability- receive pre-defined on-the-job trainings essential for area of responsibility, high responsiveness to constructive criticism and timely implementation of suggested improvements. Work environment: This position works in a typical office and/or clinical lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. Typical office environment with moderate noise levels (~20% of work hours). Uses phone, computer, office equipment and supplies on a regular basis. cGMP clean room spaces and facilities (~80% of work hours). Grade A/B/C/D GMP environment with associated facility noise levels. Uses cleanroom phone, computer, variety of equipment and reagent/supplies. General unclassified laboratory spaces, as needed. Common laboratory equipment and noise levels. While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.

Requirements

Bachelor’s Degree in Biology, Biochemistry, Biotechnology or other related field.
Zero (0) to Two (2) years of cell therapy manufacturing experience.
Legal eligibility to work in the United States is required.
Undergo and pass a color blindness evaluation and assessment of vision abilities required for this position.

Nice To Haves

One (1) to Two (2) years of cell therapy manufacturing experience.

Responsibilities

Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash.
Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs.
Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions.
Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient.
Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.
Independently perform calculations to determine cell viability, dilutions, and cell concentrations.
Completes all appropriate logs and trackers.
Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility.
Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Conducts activities to support study plans, and IQ/OQ/PQs.
Provide input or feedback regarding change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed.
Performs routine equipment maintenance and troubleshooting.
Prepares and presents manufacturing summaries, as needed.