Senior manager biosynthesis

Process Development Director

Description:


This is a senior leadership role in Process Development. The incumbent will lead the design, optimization and scale-up of manufacturing processes for biosynthetic and medical device products.


The role requires close collaboration with Technical Operations, Supply Chain and Quality teams to ensure robust, scalable and compliant processes from early development through to commercial production.



Duties & Responsibilities:


* Lead end-to-end process development lifecycle for biosynthetic and medical device products from concept through scale-up and commercial manufacturing transfer
* Develop scalable robust manufacturing processes that meet quality regulatory cost objectives drive design manufacturability designtocost initiatives Plan manage technology transfer activities FROM DEVELoPMENtTO PRODUCTION LINES INCLUDING SUPPORT INPROCESS VALIDATION IQOQPQ PARTNER FORMULATION TECHNICAL OPERATIONS MANUFACTURINGQUALITY TEAMS SELECT EQUIPMENT AUTOMATION TECHNOLOGIES EVALUATE CAPITAL PROJECT NEEDSCONTRIBUTE MANAGE BUDGET PLANNING

* Bachelors degree Chemical Engineering related field advanced degree MS PhD preferred;
* MORE THAN 10 YEARS OF EXPERIENCE INPROCESS DEVELOPMENTSCALEUPMANUFACTURINGTRANSFER MEDICAL DEVICE SIMILARLY REGULATED INDUSTRIES PHARMABIOLOGY HANDSON LEADERSHIP RESPONSIBILITIES Deep knowledge GMP ISO13485 quality systems CAPA change control document control regulatory expectations Medical Devices Proven expertise process characterization statistical analysis validation experience common areas Medical Devices polymer processing lyophilization milling coloration sterilization reliable Manufacture demonstrated success transfers Manufacturing Commercial Demand excellent project planning budget management skills ability managing multiple programs concurrent TRAVEL OCCASIONAL SITES VENDORS CUSTOMERS NEEDED LIGHT MODERATE TRAVEL}

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Benefits:
Top salary bonus pension healthcare car allowance. -----------------------------------