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Principal Scientist, Analytical Technology
Serve as the subject matter expert (SME) for commercial product testing methodologies, analytical / laboratory issues, and projects. Responsibilities will include the following:
Serve on cross-functional project teams to represent Analytical supporting Oncology products:
o Assist with process improvements and/or analytical technology transfers
o Lead method transfers and/or qualifications/validations
o Provide technical assessments for changes to methods and specifications
Serve as technical lead for laboratory related investigations and provide support for process investigations as needed.
Maintain compliance with cGMP regulations, and quickly resolve discrepancies.
Serve as the Analytical lead author and subject matter expert for post-approval CMC filings.
Serve as global change control author / reviewer for analytical.
40% Analytical Subject Matter Expert (40%):
Serve as technical lead for laboratory-related investigations and provide support for process investigations as needed.
Represent Analytical on cross-functional project teams.
Active member of tech transfer teams and take lead technical role for method transfers, qualifications and validations.
Provide technical assessments for proposed changes to specifications and methods for raw materials, API, in-process intermediates, and drug products.
In-house technical expert for drug product testing and methodology
As needed, partner with Shire s R&D function (Product Development, Regulatory Affairs) regarding testing and methodology.
30% Departmental Responsibilities (30%):
Manage analytical activities and projects to meet the strategic and project goals.
Ensure that new or existing functional projects are implemented in a timely manner, and meet requirements for quality, cost and customer service.
Ensure the timeline for technical tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip.
Directly support other Analytical staff members to assure technical aspects of all projects, initiatives, and activities as needed.
Coordinate technical documentation, ensuring accuracy, clarity, and quality. This includes protocols, test reports, stability reports, technical reports, SOPs, etc.
Maintain knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents.
Provide input for planning, budgeting, and staffing requirements to support Small Molecule Operating Unit projects and initiatives.
20% Compliance Documentation (20%):
Serve as the Analytical lead author and subject matter expert for CMC sections of Post-Approval Supplements.
Serve as global change control reviewer for analytical and ensure appropriate compliance on changes to methods and specifications.
Author / Review / Approve validation, qualification, or transfer protocols
Maintain a current understanding of FDA guidance documents pertaining to laboratory operations, specifications, stability and analytical method validation.
Ensure training is current and compliant
10% Communication (10%):
Proactively communicate across Analytical and Sm OpU
Lead and / or facilitate meetings and provide progress tracking and updates to leadership.
EDUCATION & EXPERIENCE REQUIREMENTS
Normally requires an advanced degree in a scientific/technical discipline with 8-12 years related experience or a BS with 12-15 years.
Applies expert knowledge of scientific/technical principles & concepts.
Must have method development experience and extensive troubleshooting skills and experience.
Has broad and extensive understanding of analytical techniques and testing methodologies.
Has strong understanding of quality and regulatory requirements.
Experience working with 3rd party contract manufacturing and laboratory sites.
Experience with European (or other ex-US) regulatory requirements is a plus.
Lean six sigma, DOE, and statistical skills and experience desirable.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
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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.