Material Handling Associate II - Immatics NV : Job Details

EMPLOYEE INFORMATION Entity: Immatics Us Inc. Job Level: D2 Title: Material Handling Associate II Employment Status: Full time Location Material Handling personnel may 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 Schedule: Monday-Friday 1st Shift: 0630-1500 (40-hour/week) Weekends/holidays as needed FLSA Classification: Non-Exempt/Hourly POSITION INFORMATION Position Summary/purpose

• The Material Handling Associate is a GxP position that will act in a supporting role of the manufacturing team. This role involves preparing GMP materials according to strict aseptic techniques and procedures, transferring them to the appropriate manufacturing area, and preparing the manufacturing area for use.

Essential Functions

• Supports the GMP Manufacturing team by preparing necessary materials and manufacturing suites for use.

• Request materials from materials management using a BOM or pick list.

• Accurately and aseptically performs material kitting per established pick lists according to the manufacturing calendar.

• Successfully complete aseptic gowning qualification and maintains qualified status.

• Transfers kitted materials into appropriate manufacturing location.

• Ensures materials are appropriately disinfected and ready for aseptic use.

• Scans completed pick lists and submits to the appropriate review team.

• Reconciles and returns unused, unopened materials to materials management.

• Identifies and resolves any discrepancies between picked materials and actual materials used.

• Maintains accurate documentation in compliance with FDA's Good Laboratory Practices, Good Documentation 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.

• Maintains established safety protocols.

• Provide input or feedback regarding change controls, WI, and SOPs as directed.

• Ability to provide information and feedback for study plans, reports, deviations, OOS/OOE, and CAPAs as directed.

• Provides feedback on unused or returned materials and assists in any modifications od picklists, BOMs, etc.

• Reviews pick list, BOM, process updates, or change controls, WI, and SOPs as needed

• Provides improvement/troubleshooting ideas as needed.

• Provides assistance with OOS/OOE reports when necessary

Secondary Functions

• Collaborates with materials management to ensure MOH, ROP, and BOMs are accurate. Completes all appropriate logs and trackers.

• Assists in preparation of cleanroom materials and equipment as needed.

• Provides real time feedback and ideas regarding the efficiency of the workflow.

• Enters relevant data into appropriate systems

• Reports details relevant to deviations, OOS/OOE, or CAPAs.

• Independently perform routine equipment maintenance and cleaning.

Required Qualifications

• High School Diploma/GED

• Two (2) to four (4) years of material handling/supply chain experience required.

• Experience working in a manufacturing and/or GMP facility

• Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines.

• Cold chain supply knowledge and experience in a pharmaceutical or biotech setting.

Preferred Qualifications

• Four (4) years of material handling/supply chain experience.

• Bachelor's degree in science or related field

Competencies:

• Independent Working- routine tasks with limited supervision; non-standard tasks with close supervision.

• Communication- clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor)

• Problem Solving- ability to identify, deeply analyze and communicate problems; basic ability to develop suitable solutions.

• 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 trainings essential for area of responsibility; high responsiveness to constructive criticism and basic ability to autonomously reflect on required improvements; timely implementation of suggested improvements.

• Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding.

Travel Required:

• Travel may be required between the office building and manufacturing facility on a daily basis.

Work Environment:

• 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 may handle blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.

Physical Demands:

• Carrying- to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.

• Climbing- moving up or down step stools or ladders while maintaining balance

• Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly, or quickly.

• Feeling- the ability to detect different materials or temperatures with fingers and hands.

• Gowning- sitting or standing to don or remove sterile PPE.

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

• Typing - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

• Lifting - raising or lowering an object (up to 50 lbs.) from one level to another (includes upward pulling).

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

• Undergo and pass a color blindness evaluation and assessment of vision abilities required for this position.

• Pushing - Exerting force upon an object so that the object moves away from the object. Must be able to push carts and gas tanks on rolling wheels (approximately 50 lbs.).

• Pulling - Exerting force upon an object so that the object moves toward the force. Must be able to pull carts and gas tanks on rolling wheels (approximately 50 lbs.)

• Reaching- Extending both hands and/or arms perpendicular to the floor and in front of your body towards an object for extended periods of time.

• Sitting - remaining in 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 bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscle.

Work Authorization Requirements:

• Valid driver's license and a criminal background check.