Executive Director, Biologics External Manufacturing Technical Operations

Job Description

Our Biologics External Manufacturing network spans US, EU and AP, and includes the drug substance and drug product manufacture of biologics products. The Biologics External Manufacturing Technical Operations organization provides technical oversight to established commercial products and new product introductions within this complex network.  The Biologics External Manufacturing (Bio ExM) Technical Operations lead, reporting to the Global Science, Engineering and Commercialization (GSEC) Biologics Technical Operations leader, will be accountable for managing this organization, and providing technical guidance and oversight to our external network of CMO partnerships supporting our portfolio of pipeline and commercial products (Drug Substance and Drug Product).

The qualified candidate will bring a passion for people development, a drive technical depth, and will maintain and expand collaborative partnerships with Operations, Quality and Commercialization partners to ensure that technical support flowing into established Virtual Focus Factories is aligned with the needs and expectations of each external site and aligns with the overall strategy of creating an efficient, robust, compliant, cost-effective supply for our portfolio of life saving products.

Primary Responsibilities:

In this role, the qualified candidate will drive technical rigor and structured support for technology transfer of pipeline and in line products to new and established CMO partnerships, as well as provide in depth technical support to and monitoring of establish products across our network of CMO partnerships.  They will bring practical experience and expertise across vaccines and biologics to support right-first-time technology transfer, efficient and effective resolution of complex investigations, sustained robust process performance, and continuous improvement.  This individual will also be tasked with evolving the strategy and operating model for technical support in a manner that leverages the broader capability of our Biologics S&T network to drive for scientific excellence and efficiency, while maintaining clear accountability for robust performance across all Biologics CMO partners. 

In addition to providing technical leadership, the qualified candidate will have a demonstrated ability to attract, coach and develop talent and to build an inclusive culture that leverages diverse talent to fully enable a high performing team and organization. They will foster a highly collaborative and inclusive environment within the team and across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a boundaryless organizational mindset (right people, place, time).

Education:

• Bachelor of Science (BS) Degree in life sciences or equivalent with ten (10) years of relevant biologics development, commercialization and/or operations experience

• Master of Science (MS) Degree in life sciences or equivalent with eight (8) years of relevant biologics development, commercialization and/or operations experience

• PhD in life sciences or equivalent with eight (8) years of relevant biologics development, commercialization and/or operations experience

Technical Competencies:

• Technical Expertise in the following areas: Biologics manufacture, Sterile manufacture, Engineering, and Process Engineering with a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.

Professional Competencies:

Business Acumen and Financial Management  

• In-depth knowledge of financial systems (budgets, expenses, product standards and variances.)  

• Management of a large, agile organization with resources that include full time and temporary employees providing a pipeline of talent at the site and global levels.  

• Creates awareness of cost levers across Tiers driving productivity at all levels. 

Problem Solving/ Process Improvement 

• Gathers and analyzes data and effectively responds to new, complex, or problematic situations; creates solutions that