Associate Director Manufacturing US - Princeton, NJ Princeton,US

Pleased to meet you, we are Galapagos, a dynamic growing
Biotech company with offices across Europe and in US, headquartered in
Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet
medical needs, we synergize compelling science, technology, and
collaborative approaches to create a deep pipeline of best-in-class
small molecules, CAR-T therapies and biologics in oncology and
immunology. With capabilities from lab to patient, including a
decentralized, point-of-care CAR-T manufacturing network, we are
committed to challenging the status quo and delivering results for our
patients, employees and shareholders.

We pioneer for patients. We need thought leaders and rapid thinkers,
entrepreneurs in spirit and status quo-fighters. Collaborative
innovators and perseverant idealists. We need the best-in-class. In
other words, we need you : The ‘make-it-happener’.

We are expanding our US footprint to set-up our decentralized CAR-T
network and further build our research capabilities in the US.

We are currently looking for an Associate Director Manufacturing US - Princeton, NJ

Scope of the job:

The Associate Director Manufacturing (US) provides operational leadership to drive and expand the global network of decentralized point-of-care manufacturing units for CAR-T cell therapy. The Associate Director Manufacturing (US) will build and lead a team of 10+ employees from (Sr)Process Engineers, Manufacturing Specialists, and Technicians responsible for global GMP operations, including clinical manufacturing, technology transfers, technical support, training, APV and material management.

Your role:

• Manage the CAR-T manufacturing operations at the decentralized point-of-care manufacturing sites in the US and North American region, ensuring short vein-to-vein timelines to the patients and expansion of the manufacturing network.
• Ensure the team is in place and enabled and empowered to oversee day-to-day clinical manufacturing activities at the decentralized sites, ensuring consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform.
• Manage execution of technology transfer activities by the team at the decentralized point-of-care manufacturing sites, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
• Manage a 24/7 global technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.
• Manage Aseptic Process Validation (APV) and Aseptic Operator Qualification (AOQ) strategy, planning and execution. Manage production training, providing onsite and remote training to production personnel at the decentralized sites.
• Manage elaboration of electronic batch records, SOPs, protocols, risk assessments, position papers, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
• Establish a process and team for the preparation of GMP material kits ensuring timely material supply to the sites.
• Ensure the team is established to support Process Validation lifecycle activities, through the stages of process design, process qualification and continued process verification. Support in authoring and reviewing of regulatory filings and health authority questions related to technical process/CMC.
• Support initiatives of operational excellence in the decentralized network of point-of-care manufacturing sites, production capacity modelling, automation/digitalization, production scheduling, cost of goods analysis, lean manufacturing, six sigma, data management, process/product monitoring, 5S, Kanban, etc.
• Ensure close collaboration with leadership within all operational and support departments to establish clear workstreams and efficiency.
• Collaborate to establish governance models supporting all operational aspects, ensuring continuous improvement and compliance across all operational aspects.
• Represent the Manufacturing team in PQRB discussions with PMUs and internal and external quality representatives.
• Align with the Manufacturing Leadership Team on definition of objectives and goals and drive the team towards meeting targets.

Who are you?

• BSc/MSc degree in life sciences, biotechnology, engineering or related discipline
• 6+ years experience, including 2+ years people management experience
• Experience with management of contract manufacturing organizations
• Experience with GMP manufacturing, technology transfers, process validation, cell & gene therapy processes, automated bioreactors, regulatory inspections.
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Result-driven and can-do mindset, without compromising quality and compliance
• Good interpersonal skills and written and spoken fluency in English

What’s in it for you ?

You will be part of a fast growing and amazing company and member of
the Business Development team. As ‘make-it-happener’ you will get all
the support you need to make your job successful. At Galapagos we aim
to recruit the best people, who stand out among their peers, with
integrity and excellent interpersonal and organizational skills. Our
employees are the strength behind Galapagos, a highly motivated team,
eager to maintain Galapagos’ leading position and achieve breakthroughs
in pharmaceutical research. Galapagos offers a competitive remuneration
package and a dynamic work environment.

We are Galapagos : together we can make it happen…!