Job Title:
Production Operations Specialist
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Description:
Company Overview
In a world where complex diseases are prevented, treated, and cured, innovative treatments offer hopeful prospects to patients where other therapies have failed. Our team is dedicated to advancing the promise of immunotherapy in the treatment of multiple myeloma.
We are seeking a highly skilled Production Operations Specialist to support our Autologous CAR-T program in EMEA. This role will be part of our Operations Team, responsible for ensuring daily operational activities align with organizational goals and financial objectives.
The ideal candidate will possess strong knowledge of aseptic manufacturing, detailed understanding of shop floor manufacturing processes, and excellent communication skills. As a key member of our team, you will contribute to the design, maintenance, and continuous improvement of operational support activities within manufacturing.
Responsibilities
This position encompasses a range of tasks, including:
* Liaison between operations teams and pre-processing activities (sterilization and kitting), facilitating communication, resolving issues, optimizing processes, and ensuring seamless collaboration to enhance overall production efficiency.
* Leading business review meetings with external partners, presenting performance data, identifying issues, proposing action plans, and ensuring accountability for continuous improvement and operational execution.
* Demonstrating strong business acumen and financial knowledge to ensure operational activities align with organizational goals and financial objectives.
* Driving continuous improvement, regularly tracking and analyzing key performance indicators (KPIs) to assess production efficiency, material usage, quality, and delivery.
* Developing, reviewing, and approving robust operational documentation frameworks and ensuring adequate training of the organization.
* Participating in Change Control/Technical Board, Quality Improvement Plan (QIP) meetings, and Operational Performance Review meetings, contributing to root cause investigations and developing, reviewing, and approving CAPA plans.
Requirements
To succeed in this role, you will need:
* A Master's Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …).
* Minimum 5 years of relevant work experience, preferably in aseptic manufacturing.
* Strong knowledge of aseptic manufacturing, detailed understanding of shop floor manufacturing processes, and excellent communication skills.
* Ability to thrive in a rapidly changing environment, prioritize tasks, and manage multiple responsibilities simultaneously.
* Experience with team-based collaborations and analyzing financial/supply chain processes, understanding key metrics, and evaluating financial/supply chain performance.
What We Offer
We provide a dynamic and innovative working environment, offering opportunities to continue to develop and grow in an extensive and strong organization. You will receive an open-ended contract and a competitive remuneration package. Additionally, you will have the opportunity to participate in a progressive treatment that gives hope to patients in need, help shape a new venture from the start, and gain deep knowledge & expertise in a highly innovative and future-oriented environment.