Principal Manufacturing Associate

ImmaticsHouston, TX
3dOnsite

About The Position

Join Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. 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. We are seeking a Principal Manufacturing Associate to support our CMC-GMP team. This individual will be responsible for overseeing daily GMP operations and serving as the on-the-floor subject matter expert (“man-in-plant”) for all IMA20x manufacturing processes and activities . The Team Lead will play a critical role in ensuring adherence to GMP standards, supporting cross-functional coordination, and driving operational excellence in the production of our cell therapy products.

Requirements

  • Biomanufacturing Technology Associate of Applied Science Degree, Biomanufacturing Technology Level 2 Certificate, or equivalent. or Associate degree in biology, Biochemistry, Biotechnology, Biomanufacturing or other related field.
  • Seven (7) or more years of cell therapy manufacturing experience, or four (4) to five (5) years of cell therapy manufacturing experience combined with lead or supervisory experience.
  • Independent Working- no active supervision for routine tasks; minimal supervision on non-standard tasks.
  • Communication- advanced verbal communication; clear and efficient written communication; common courtesy; regular interaction with other teams or departments; basic presentation skills (efficient presentation of own work to small groups/own team).
  • Problem Solving- ability to identify, deeply analyze and communicate problems; advanced ability to develop and implement solutions within own area of responsibility.
  • Critical Thinking- advanced reflection on standard and non-standard processes; timely identification of need and room for improvement within own/narrow scope; ability to anticipate future risks; basic understanding and consideration of interfaces beyond own/narrow scope.
  • Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities; pro-active contribution to development of the team structure and lab processes (beyond own tasks).
  • Organizational & Prioritization Skills- advanced organizational skills required to structure work schedules beyond own daily tasks according to (and beyond) predefined work packages for standard and non-standard lab processes; deep understanding of priorities within own/narrow scope; prioritization requires minimal interaction with the manager.
  • Coachability- actively reflect on and suggest trainings supporting professional development within or beyond current area of responsibility; high responsiveness to constructive criticism and ability to autonomously reflect on required improvements and propose self-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 level in specific area of expertise; train C level during onboarding.
  • Legal eligibility to work in the United States is required.
  • Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Nice To Haves

  • Master’s Degree in Biology, Biochemistry, Biotechnology, Healthcare Administration or other related field.
  • Seven (7) years of cell therapy manufacturing experience.

Responsibilities

  • Knowledge of current cGMP.
  • Provide instruction to facilitate workflow, shift activities, and shift exchange ensuring all activities are completed as assigned.
  • Provide a safe and controlled work environment.
  • Responsible for investigating and troubleshooting deviations and unexpected events and is the person of contact for deviation initiation and completion.
  • Maintains competency status to serve as backup for manufacturing associates for daily manufacturing processes.
  • Serves as backup for reviewing executed batch records and documents.
  • Responsible for coordinating with the Training Department to include training needs on the manufacturing schedule.
  • Collaborates with the MSAT/PD teams to transfer new projects into GMP.
  • Works cross-functionally and in collaboration with internal groups to develop or update internal policies, procedures or steps, identifies and escalate risks, communicates changes and plan for execution.
  • Leads routine team meetings.
  • Ability to work productively and to participate in a highly creative and fast-paced environment.
  • 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.
  • Assign and schedule all manufacturing activities.
  • Performs preliminary review of completed BRs and worksheets prior to CMC and QA review.
  • Determines required corrective actions resulting from deviations or CAPAs and develops implementation plans.
  • Acts as CAPA lead when required.
  • Reviews and ensures completion of all manufacturing related logs.
  • Leads implementation of new equipment including but not limited to execution of IQ/OQ/PQ, associated SOP, and maintenance documentation.
  • Analyzes/summarizes data for various reports/presentations as needed.
  • Performs tours for vendors, employees, and guests.
  • Coordinates annual equipment PM schedule.

Benefits

  • Competitive rates for Health, Dental, and Vision Insurance
  • 4 weeks of Paid 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.
  • 100% Employer Paid Short- and Long-Term Disability Coverage
  • 401(k) with Immediate Eligibility  & company match… 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 employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
  • Partially 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.
  • 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.
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