Primary Role: This incumbent will be primarily responsible for providing analytical method development and product characterization support for the Process Development technical groups for programs entering late and commercial product development cycles. Analytical Development department interfaces with multiple groups including cell line and cell culture development, Purification and Drug Product Development. The role is focused on the following areas: * The Director will be responsible for guiding the commercialization of analytical methods that are fit for purpose and meet current agency expectations. In addition he/she will be required to apply physicochemical and biological characterization strategies to aid structure/function studies in support of QbD, comparability studies, etc * The Director should be prepared to develop the department's technical and product development capability and manage a pool of scientists and analytical specialists at various stages of their careers with the ultimate goal of developing a high performing team that meets multi-product development business needs. Knowledge and experience in cGMP analytical work is required. * Accountable for driving resolution of biologics manufacturing process challenges, for ensuring knowledge management and sharing of best practices for biologics DS/DP tech transfers and commercial process lifecycle management. Reviews and approves protocols and technical reports, ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support changes/improvements. * Contributes towards developing and governing harmonized business processes and tools related to development, tech transfer and commercial product management Responsibilities: * Reviews and approves protocols and technical reports, ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support changes/improvements. * Team provides process support to internal and external manufacturing sites, manages the resources, leads technical initiatives, and process knowledge management. * Prioritizes work and deploys resources to ensure that all projects are successfully executed. Key accountability is to provide technical leadership and technical capabilities to Process Development and MS&T. * Provide technical leadership in various governance committees and functional, cross-functional and program-related decision making bodies. Education & Experience Requirements: PhD with at least 15 years experience in developing analytics for proteins/antibodies and/or small molecules, writing regulatory submissions of CMC sections, and managing scientists and technical personnel. * Working knowledge of GMP compliance as related to analytical laboratory * Technical expertise in analytical chemistry * Strong and effective people management and interpersonal skills, and demonstrated leadership to provide direction to a large department in a fast paced, multi-product biotech company * Ability to communicate clearly and concisely verbally and in writing; specifically has demonstrated strong experience and skills in authoring regulatory submissions * Demonstrated technical project management experience to develop integrated short term and long term project plans * Team player with excellent interpersonal skills Key Skills and Competencies: * Technical excellence in analytical chemistry * Clear and concise written and oral communication skills, with capability to position regulatory technical contents in the CMC area * Strategic agility and effective influence management skills * Strong track record of collaboration, stakeholder relationship management, and influencing colleagues and key decision makers * Demonstrated ability to successfully manage multiple functions and activities, including people, financials, business processes, and projects and to provide focus, direction and prioritization to navigate in a fast paced environment. * Flexible, open to new ideas and strategies * Extensive knowledge in multiple facets of biologics technical development, manufacturing and quality * Demonstrated ability to drive for results and lead innovation and change * Strong change management skills and demonstrated ability to simplify and improve business processes * Excellent communication skills and ability to communicate effectively across levels and functions * Ability to create a high performance culture with non-direct reports Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.