Manage a team that provides technical leadership for Biologics Drug Product for commercial and late clinical stage product portfolio in the Biologics Operating Unit. This team will serve as the technical bridge between Process Development and site based or external TS groups. This team will liaise closely with the US and EU External manufacturing technical services teams to:
• Support major investigations: Drive investigation plans, coordinate lab studies and study reports
• Provide regulatory support: Author/review sections & responses for global submissions, Support regulatory inspections, Address compliance gaps per new regulatory/quality requirements, review external APQRs
• Support the Post Approval Lifecycle Management plan (PALM) in coordination with Product Strategy (PONE)
• Support tech transfer (and change control if mfg related)
• Provide technical input to QbD including commercial requirements.
• Provide process risk assessment
• Participate in Due Diligence and integration into Shire
Critical investigation support
Education & Experience Requirements:
• At least 8 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
• Master degree or PhD in technical / scientific education, pharma - process engineering is preferred
• Experienced people manager enabling to connect teams with each other
• 6 Sigma and Statistical knowledge
• Broad knowledge and experience within the GMP environment, and regulatory affairs
• Very successful track record of change management projects and processes
• High level of customer orientation and organizational skills
• Flexible in mind / out of the box thinking
• Enthusiastic, decisive, motivating and convincing personality
• International background appreciated
• Excellent communication skills, verbal and written communication skills
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.