Shire Principal Scientist, Cell Banking in Lexington, Massachusetts
This individual will be a member of the group responsible for developing GMP cell bank manufacturing processes for clinical and commercial programs; defining appropriate characterization activities for evaluation of production cell banks and cell lines, and managing cell banking activities throughout the program lifecycle.
Providing technical leadership in developing GMP cell bank manufacturing processes, characterization and testing strategy
Identifying and driving technical innovations leading to improvements of production cell lines and cell banking processes
Building strong collaborations with cell line development, cell bank manufacturing, quality control and regulatory groups to align activities to rapidly advance Shire pipeline
Drafting/reviewing the content of relevant the CMC sections of regulatory dossiers, supporting regulatory queries and inspections.
Providing input into organizational policies and guidance documents related to cell bank life cycle management
Mentoring and enhancing staff performance
Development related work and associated documentation
Identifies the objectives of cell banking group
Oversees the timely development, characterization testing of cell banks, communicates with the departments involved
Manages preparation of internal documents, reviews SOPs, study reports project summaries in the area of cell culture process development, cell banking and testing
Authors relevant CMC sections of US and international re gulatory submissions and addresses post-registration questions
Serves as subject matter expert for regulatory inspections in the areas of cell banking process, cell bank and cell line characterization and testing
Designs and directs the studies to address post marketing commitments
Evaluation of new technologies
Provides technical leadership in the pursuit of new technologies for improvements of cell line performance as well as cell banking process with the ultimate goal of rapid generation of clinical material meeting quality targets
Organization support and cross functional responsibilities
Works with the manager to identify and drive group’s goals; coordinates/leads the activities of cross functional project teams, and interdepartmental teams. Serves as a liaison and provides PDB input to cell line development function
Effectively leads, trains and mentors group of direct reports
Education and Experience Requirements
PhD in Biological Sciences or Engineering degree; > 8 years of relevant experience including 4-6 years the industry
Proficiency in regulatory requirements for drug development and cell banks manufacturing and testing
Excellent writing skills including authoring regulatory filings are required.
Key Skills, Abilities, and Competencies
Knowledge and industry expertise of advanced scientific principles, practices and standards to biologics process and product development
Current scientific knowledge and latest technologies in areas of cell line development, cell banking and cell culture process development
Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment
Ability to deliver results consistently and effectively
Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers.
High degree of self-motivation
Ability to quickly adapt to changing business conditions
Complexity and Problem Solving
Independently defines his/her assignment objectives based on the input from management, designs and directs experimental strategies to be carried out by others. Makes sound and timely decisions on deliverables and resources based on corporate and functional priorities
Independently leads the design and execution of studies to troubleshoot issues encountered during development or GMP manufacturing.
Provides high quality drafts of relevant CMC sections of regulatory filings and submissions addressing post-registration questions; proposals for development and research projects, publications in field of expertise. Reviews/approves documents such as protocols, memos, data summaries, reports and procedures
Presents at department and cross-functional gatherings, project team meetings and external meetings.
Works with management to review progress and strategy in meeting team objectives.
Internal and External Contacts
Sr. Director, Upstream Development and his staff
Quality Control staff
Global Regulatory staff
Contract Manufacturing Organizations
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.