Process Development Scientist – Sterile Fill – FILLED
The Wellington Group has been engaged to find a Process Development Scientist – Sterile Fill for the support of aseptic / sterile fill operations of biologics manufacturing for a new flagship project within a leading biologic /vaccine company. This is a great opportunity to apply your Manufacturing experience in biologics to lead the sterile fill functions of current products and Phase III research products.
Process Development Scientist – Sterile Fill eesponsibilities include:
- Oversee the aseptic / sterile fill operations for both current and incoming / clinical scale biological products
- Responsible for the execution of new technologies and fill techniques
- Transfer of processes from R&D in to IO for new vaccine products, industrialization of processes and methods, definition of user requirements for appropriate equipment, scale-up definition, develop and drive execution process validation and consistency runs, support manufacturing and release of Ph3 clinical lots
- Product and Process improvements to meet site IO metrics for licensed vaccine products (HSE, compliance, Cost of Goods), Marketing driven projects, product transfers between buildings in same site or between sites
- Act as a SME in specific area to support SPP and focus factory leadership to troubleshoot process related critical/major deviations and completion of work requests
- Direct and/or collaborate with Manufacturing Technology staff for assigned activities.
- Participate/Lead on Global and Local Project Teams. Provide technical support for manufacturing departments through the Product/Process Teams
The qualified candidate will have:
- Ph.D. in biological sciences/biological engineering with 5 to 7 years industrial experience in a cGMP environment
- Experience with aseptic processing with sterile products is a must
- Hands on knowledge with Fill operations, clean rooms, GMP regulations for aseptic manufacturing and Sterile Fill
- Experience in team leadership is desirable. Note: multiple positions are available with focuses being bacterial fermentation, purification, formulation and filling
Permanent position with a growing company offering great benefits, salary, bonus and relocation assistance.
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)