Analytical Product Owner Principal Scientist
Location:
, Massachusetts
Posted:
December 04, 2017
Reference:
R0015035
Position Summary:
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
teams
- Manage analytical development plan and provide technical justification of
product specification
- 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

Requirements:

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.


A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

Know someone who would be interested in this job? Share it with your network.