Principal Manufacturing Associate - Team Lead - Second Shift

Immatics N.V.•Houston, TX

69d•Onsite

About The Position

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. We are seeking a Principal Manufacturing Associate - Team Lead 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

Bachelor's Degree in Biology, Biochemistry, Biotechnology 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.

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 Insuranceâ¯up to at 1x annual salary, up to 100K ( club together)
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibilityâ¯ & 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 Leaveâ¯for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illnessâ¯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.