Description
The Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule
You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
RESPONSIBILITIES
The Operations Supervisor will lead and supervise multiple units within the process operations (i.e. component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
The Operations Supervisor will need to build strong partnerships with Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain / Warehouse to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for technicians and experts on the production floor.
Company
Our client, a biotech company, based in Zwijnaarde, is a global biotechnology company bringing the innovative cell therapy to Ghent. With this, the team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases.
They are currently in a phase of strong growth and are looking for motivated and dedicated team members.
Profile
Education
* Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
Experience
* A minimum of 5 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
* At least 3 years of aseptic GMP manufacturing experience (grade A/B or C).
Capabilities, Knowledge, and skills:
* Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
* Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
* Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
* Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
* Strong analytical, problem solving, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
* Can do attitude, Right first time and Hands-on approach
* Self-motivated, enthusiastic personality, team player
* Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
* Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
* An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
* Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
Offer
* You will join an exciting pharmaceutical company with opportunities for growth.
* You will work within a strong and respectful diverse team where everyone is welcome.
* You will receive an attractive salary package including meal vouchers and eco vouchers.
* Hospitalisation insurance, group insurance and bonus complete the salary package.
* You will work in a 2-shift system (6 am - 4 pm / 2 pm - 00 am) in a regime in which you work 4 days, have 4 days off, etc. This gives you a nice balance between Work and Personal life
* You will work in an environment where loyalty and team spirit