Executive Director, Biologics Technical Product Leader

Job Description

The Biologics Technical product leader role is responsible for technical leadership and oversight for all biologics molecules end to end.  This includes both pipeline and in line products.  For pipeline, this includes development and implementation of pipeline commercialization strategy to ensure on-time launch with the best science and most robust processes working closely with DCRC.  For inline, this includes development and implementation of technology roadmaps that proactively ensure reliable supply in alignment with the franchise objectives as developed by the value chain team for each product.

This role ensures ownership for the products’ technical processes and associated technical challenges.

Primary Responsibilities:

• Managing the portfolio of technical projects associated with the Biologics products. Using standard tools and processes to enable prioritization, resource allocation and ensure project outcome realization.

• Working collaboratively with the GBO OpU and associated VCMT’s to align on prioritization and strategies for the delivery of the business needs, in particular for the in line products. Ensuring that the team works with urgency to support the E2E supply chain when issues arise to ensure minimal risk to supply or compliance.

• Developing tools and processes to ensure we are holistically looking at our products and their performance, using data to inform us of stability concerns or potential risks to our compliance posture or continuity of supply

• Provide deep technical oversight of projects within the technical portfolio of products in partnership with the broader LMS&T organization. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by teams supporting in line and pipeline products. Expectation is that this leader will provide a structured approach to technical leadership that enables clear prioritization of the work aligned with the business needs, working with key stakeholders and decision makers.

• Coaching and developing the technical leaders so they are able to support organization and all the complexity that exists today. Ensuring team are continuing to develop their knowledge and skills,  It is required that this leader will create an environment through expectations, culture and processes which nurtures and demands both technical excellence and executional excellence. Ensuring reliable launch and sustained supply are achieved and there is both technical knowledge continuity and technical project continuity as the product passes from pipeline to inline.

• Required to comply with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

• Work collaboratively to drive a safe and compliant culture in GSEC and within the teams that they interact with.

• May be required to perform other duties as assigned.

Education Minimum Requirement:

• B.S. /M.S. /Ph.D. in one of the relevant Engineering or Science fields

Required Experience and Skills:

• Minimum of 10-15 years experience in biopharmaceutical manufacturing and/or development, preferably a majority spent in science and technical role.

• Demonstrated technical excellence an in depth understanding of biologics molecules, manufacturing processes and commercialization principles

• Experience of biologics development and new product introduction.

• Strong cross divisional networking skills and capabilities

• Experience in Technical product stewardship an advantage

• Demonstrated functional and enterprise leadership, ability to influence at all levels of the organisation.  

• Strong collaborative and talent-building skills and the ability to work strategically and in a detail-oriented framework with all levels of management.

• Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment

Core Competences:

Technical

• Deep knowledge and experience of working in a leadership role in the manufacture and/or development of biologic drug substance and/or  drug product is required

• Proven record in technical problem solving in a complex manufacturing environment