Associate Quality Control Manager

FLSA Classification: Exempt/Salary

Schedule: Monday to Friday; 8:00am to 4:30pm; occasional off-shift hours and weekend or holiday shifts

Department: Global Quality Operations

Reports to: Associate Director - Quality Control

Supervisory responsibilities: Yes

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

Position Summary/objective:

The main role of the Associate QC Manager is to provide oversight of QC personnel who conduct in-process and final product testing of Immatics' GMP products and manage the day-to-day scheduling and activities within the QC Department.

Essential functions:Management

• Lead by Example: Earn team trust through consistent attendance, integrity, transparent communication, and reliable execution of tasks.

• Effective Hiring: Select team members who fit the job requirements, company culture, and team dynamics.

• Organize and Manage: Efficiently manage team schedules, assignments, and workload distribution.

• Frequent Communication: Ensure team members have the necessary information and tools through regular communication.

• Support and Develop: Set goals, measure achievement progress, provide constructive feedback, resolve conflicts, and coach team members for growth and development. Recognize and give credit to team members when they so deserve - publicly and privately.

• Scheduling and Staffing: Organize daily QC schedules and ensure appropriate staffing.

• Assay Performance and Support: Perform, review and support release assays for cell product identity and safety, which includes the use of different laboratory methods such as microscopy, visual inspection, cell count & viability, flow cytometry, cell culture, and immunoassays.

• Data Management: Extract, compile, analyze data, generate reports while maintaining data integrity.

• Compliance and Documentation:
  • Conduct and document activities per cGMP/GxP, regulatory requirements and written procedures.
  • Write and review QC testing procedures and plans, validation plans, and reports for QC testing, assays, and equipment.
  • Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.

• Inventory and Equipment Management: Manage, in collaboration with other team members, supply inventory, equipment maintenance, and assay qualifications and validations.

• Transport human biological samples, controlled documents, materials and other required items between facilities and/or laboratories.

• Demonstrate exceptional initiative and problem-solving skills, while being detail-oriented in approach to every task.

• Strong analytical, technical writing, verbal communication, presentation and interpersonal skills

• Ability to work independently and manage multiple projects with aggressive timelines

• High level of self-awareness and emotional intelligence

• Demonstrates the highest level of ethics, integrity and trust while acting with courage and candor

• This position works in a typical office and lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Other duties performed while outside of office and lab building could involve exposure to manufacturing operations, along with outdoor conditions (including highway traffic) and temperatures.

• While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or caustic chemicals. The employee can be occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. This position requires handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals.

• 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.

• 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 of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may 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 - 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 muscles.

• 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

• Laboratory skills should include cell culture and any of the following: microscopy, visual inspection, cell count & viability, flow cytometry, immunoassays, DNA isolation, PCR, sterility, endotoxin, and mycoplasma

• Experience writing either GxP deviations, lab investigations, OOS/OOE, CAPAs, or change controls.

• BA or BS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering

• Laboratory skills should include cell culture experience and more than one of the following: microscopy, visual inspection, cell count & viability, flow cytometry, immunoassays, DNA isolation, PCR, sterility, endotoxin, and mycoplasma