This is an exciting, frontline, technical role in a rapidly growing biopharmaceutical company, where we outsource 100% of all our manufacturing, packaging and testing activities. This key role supports new product and technology introductions, transfers, and technical oversight of commercial products within the Small Molecule Operating Unit of Shire Technical Operations. Products supported are complex, sterile and non-sterile, modified release, solid oral dosage forms with synthetic molecule active ingredients.
This position will be the primary technical point of contact for the SM Ops organization with our internal, Pharmaceutical Development and external, Contract Manufacturing Organizations. The primary role of this individual will be to own, understand and continuously improve the process capability and supply chain resiliency for the products within their assigned product portfolio. Roles and responsibilities include, but are not limited to:
• Technology selection and acquisition
• Process design, development, optimization and verification
• Technology transfer & Process Validation
• New product introduction
• Continuous improvement
• Routine technical support
This position reports to the Sr. Director/Head, Drug Product Technical Services group. A Technical Ladder exists in the SM Ops unit and Scientists / Engineers have an opportunity to progress their career as individual contributors up to the level of Senior Director / Technical Steward.
40% • Lead and /or support new product technology transfer to CMO sites, globally:
o Define capabilities required at the CMO to successfully support new product introduction.
o Assess gaps in capabilities and implement plan to build required capabilities at CMO to support technology transfer.
o Assist the Pharmaceutical Development group with technology selection, process design, development and optimization
o Design, develop and optimize product manufacturing processes using robust DoE and QbD principles.
o Author, review and approval of relevant technical documentation, protocols, reports, and regulatory submissions, including but not limited to Basis of Design, Process Risk Assessment, Technology Transfer Plan, Validation Master Plan, etc.
o Ensure that all technology transfers and Process Validation are right first time, and are implemented in a timely manner while meeting the requirements for quality, cost and customer service.
40% • Serve as in-house technical expert for assigned products, responsible for supporting all ongoing commercial programs and assuring a robust and resilient supply of products:
o Develops, maintains and acts on comprehensive risk register for their product process.
o Prioritize and drive investigation processes to closure, using standardized approaches, such as KT and A3, to timely closure such that supply is not negatively impacted. Ensure that timeline for tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip.
o Facilitate communication between the departments, including meetings facilitation, progress tracking, and updates to supply chain leadership.
o Manage and maintain change control throughout appropriate product groups.
o Development & maintenance of technical product knowledge database and technical documents for assigned products. Dissect and interpret data from various sources, using that information to create scientific reports that when compiled represents a documented summary of known product knowledge.
20% • Continue to grow as a respected technical leader by;
o Building and maintaining a network of robust relationships with Regulators, Suppliers, CMOs, OEMs and Key Opinion Leaders in their respective technical field.
o Actively engaged in professional industry forums with an eye towards staying current.
Education & Experience Requirements
• Normally requires an advanced degree in a scientific/technical discipline with 12-16 years technical hands-on industry experience in development and/or manufacturing (both highly preferred) or a BS with 14-18 years. Applies expert knowledge of scientific/technical principles & concepts.
• Minimum of 10 years technical hands on process engineering experience with one or more of the following: modified release oral solids, liquids, sterile parenteral and high potency formulations.
• 5 years + direct experience in supporting manufacturing at CMOs
• Previous experience of effectively managing global technical projects
• Recognized as an expert or leader in their specific field.
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.