The Principal Scientist is accountable for the technical continuum of analytical methods and strategies
from early stage to end of commercial shelf life.
· As an expert in analytical development of biologics, serving as the point of
contact on the leadership for analytical control strategy and analytical support
for early development stage to commercial biotherapeutics
- Responsible for strategic planning, coordinating, and execution analytical
development, characterization activities and developability assessment
- Contribute as part of a team of scientists to guide the development of analytical
methods/projects from early clinical development through commercialization
and life cycle management.
- Create and maintain effective partnerships with stakeholders from Analytical
Development, Process Development, Technical Services, Quality, Regulatory,
Project Life Cycle Management, and Manufacturing to deliver analytical
strategies with a high probability of technical and regulatory success.
- Provide technical partnership for testing laboratories and process development
- Manage analytical development plan and provide technical justification of
- Authoring/reviewing regulatory filing CMC analytical sections and responses to
health authority questions
Coordinates optimization and improvement of analytical program support
Job Function and Description
25% of Time: Owns the analytical control strategy aligned with the Shire sourcing strategy for a product family
20 %: Owns the analytical development plan for a product family
10 %: Single point of contact outside of Analytical Development (other PDTS departments, CMC team, Regulatory, MFG, QC and Quality Management PQLs etc)
10 %: Contributes and signs-off on all analytical chapters in IND/IMPD/BLA/MAA (development analytical methods, justification of specifications, impurities, characterization etc)
10 %: Represents Shire Process development biologics and analytical development group at authority meetings and telecom for analytical questions
10 %: Ensure a continues information flow between the AD analytical method development, characterization, innovation & PAT, high-thru-put test center
10 %: Collaborate with cross functional stakeholder to develop and optimize business process to ensure successful implementation of analytical control strategies
5%: Contribute to develop of an operating model and continuous improvement of platforms based analytical development plans for the complete product life cycle for product families as the company grows
Recognized analytical development expert with extensive experiences on method development, characterization and CMC analytical strategy in biologics development, proven records of serving as analytical project lead for clinical and/or commercial products, proven successful regulatory agency interaction experiences. PhD preferred. MS with extensive experience will also be considered.
Location/Region: Lexington, MA