Executive Director, Head of Manufacturing Science & Technology About the Company Innovative biotechnology company
Industry
Biotechnology
Type
Privately Held
Founded
2016
Employees
51-200
Categories PharmaceuticalsBiotechnologyHealth CareMedical DevicesAcademic ResearchDelivery ServicesMedicinesManufacturingMedicineChemical Products About the Role The Company is in search of an Executive Director, Head of Manufacturing Science and Technology to spearhead the transformation of biologic therapy delivery. The successful candidate will be at the forefront of a revolutionary ultra-high concentration microparticle technology platform, with a strong focus on at-home subcutaneous self-administration. This pivotal role involves leading pilot plant manufacturing, technology transfer, and technical life cycle management for the company's patented and proprietary formulation process. The Executive Director will be responsible for all aspects of manufacturing support, from pre-clinical stages through to commercial launch, and will manage a diverse team of Engineer/Scientists. The position demands a strategic leader who can navigate the complexities of multiple technology transfer programs and is adept at working across various functions both internally and externally.
Applicants must have a minimum of 15 years' experience in a cGMP/cGCP environment, with a significant background in biologics, and at least 10 years' specifically in aseptic bulk formulation and filling processes. The role requires a candidate with a proven track record in process technology transfers and experience in supporting the start-up of new manufacturing sites. The ideal candidate will have a BS and MS in Engineering/Sciences, with a PhD being a strong plus, and should be well-versed in worldwide regulatory requirements. Key responsibilities include establishing and managing GLP pilot plant manufacturing operations, leading process improvement initiatives, and ensuring that manufacturing processes are in line with the company's 5-year manufacturing strategy. The individual will also be instrumental in the creation of technology transfer plans, business cases for process improvements, and CMC regulatory documentation. Strong leadership, communication, and organizational skills are essential, as is the ability to inspire change and build new processes within a diverse, matrix organizational environment.
Hiring Manager Title
SVP, Head of Technical Operations
Travel Percent
50%
Functions Non-Profit ManagementInformation TechnologyEngineeringMedical Care/Hospital Administration
