AVP, Biologics Technical Operations

Job Description

The Biologics Technical Operations lead, reporting to the Global Science, Engineering and Commercialization (GSEC) Large Molecules Technical Operations leader, will be accountable for providing technical support to our internal and external network of biologics sites (Drug Substance and Drug Product) for both commercial and pipeline products. The Biologics Technical Operations lead will partner closely with Biologics Manufacturing Operations leaders to ensure that technical support flowing into site Integrated Product Teams (IPTs) is aligned with the needs and expectations of each site and aligns with the overall strategy of creating an efficient, cost-effective supply for our portfolio of Biologics products.  They will also partner closely with the Vaccines Technical Operations lead to enable shared learnings, integrated evolution of best practices, and leverage efficiencies across modalities. The individual biologics site technical operations/Manufacturing Science & Technology (MS&T) leaders will report into the Biologics Technical Operations lead.

In this role, the qualified candidate will be tasked with continuing to evolve the strategy and operating model for technical support in a manner that leverages the broader capability of the Large Molecules Science & Technology (S&T) network to drive for scientific excellence and efficiency, while maintaining clear accountability for robust performance across all Biologics products.  This individual will bring a breadth of experience across different types of Biologics molecules to support the continued growth and evolution of our Biologics business. They will provide the necessary technical leadership, oversight and support for technology transfer of new and existing products across the entire Biologics portfolio, as well as provide in depth technical support and monitoring of established products across our network of sites and CMO partners. They will bring additional depth of experience and rigor to support right-first-time technology transfer, sustained robust process performance, and continuous improvement across our Biologics portfolio. 

In addition to continuing to develop technical depth within this organization, the qualified candidate must have 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 create 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). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing across the broader Large Molecules organizations in the flow of the core work. They will also establish productive partnerships with Biologics Operations leadership to support seamless integration of Tech Ops/MS&T teams within each site, with a focus on delivering value.

Education:

• BS, MS or PhD in Engineering, Pharmaceutics, Science or Equivalent and a minimum of 20 years’ experience post BS.

Technical Competencies (Core S&T Functional Competencies):

• Technical Expertise in Biologics drug substance and drug product development and manufacturing

• External manufacturing experience

• Biologics DS (upstream, downstream) and DP knowledge and understanding

• Low bioburden and/or sterile processing expertise

• Process sciences laboratory management experience

• Demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results within a commercialization/ manufacturing environment

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.

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

Problem Solving/ Process Improvement

• Drive data driven outcomes in support of new, complex, or problematic situations; creates solutions that drive value for our company and our customers, incorporating innovative approaches.

• Drives technical excellence by modeling and teaching scientific problem-solving approaches to group a