Shire Sr. Principal Expert Process Validation in Lexington, Massachusetts
The Process Validation Sr. Principal Expert (Associate Director) is a member of the Process Development and Technical Services (PDTS) Organization.
Represents the PDTS PV Strategy function in project and/or CMC teams and interfaces with various other departments (e.g. Process Development, Technical Services, Engineering, Quality Validation, Manufacturing) as well as with CMOs, providing input and industrial insights for strategic planning.
Acts as an expert within the Process Validation discipline.
Establishes operational objectives and assignments. Objectives are reviewed by senior management to determine success of operation.
Is responsible for the development and implementation of process validation strategies for PDTS CMC programs. Ensures that the PV strategy of manufacturing processes meets regulatory agency requirements, internal company standards and current industry practices.
Is responsible for the development and/or review of necessary PV documentation including PV Strategy Dossier or Process Validation Master Plan, protocols, reports and related regulatory filing sections.
Provides process validation expertise and recommendations for major/critical process deviations.
Contributes to the implementation of Shire’s process validation program through the successful integration of QbD elements in process and product development.
Leads the development of corporate and/or organizational policies, guidelines and standards regarding PV strategy across several functions
Proactively drives and takes decisions within the area of responsibility Proactively drives improvement by applying innovative, creative and purpose driven solutions.
Represents Shire in global internal and industry networks
Essential Job functions include:
Provide leadership support to PDTS and CMC teams regarding PV strategy and execution for projects with moderate risks and resource requirements. Explain and communicate difficult concepts and negotiate to adopt a different point of view. Identify and commmunicate risks and provide mitigation strategies, as needed. Lead coordination of information to ensure ongoing program/process execution (25%).
Own processes/programs/ projects cross-functionally and globally (5%).
QbD/PV related strategic tasks (Shire and CMO) (70%)
Develop, Author, review and/or approve PV Strategy Dossiers and other documentation relative to QbD and PV activities (Documents related to QbD steps, e.g. CQA assessment, Process Criticality assessment, Control Strategy, PPQ protocols and reports, comparability protocols, consolidated validation reports, regulatory submission documents, etc.); provide technical support in case of critical process-related deviations in terms of root cause investigation and implementation of corrective and preventive actions (20%).
Provide guidance in regards to the development and definition of PV and Control strategies (e.g. number/kind of studies, small scale vs. large scale, number of lots, test program & limits) in various stages of the product life cycle; support facilitation of manufacturing process related risk assessments; explain and defend the PV and Control Strategy towards internal and external stakeholders (15%).
Lead / facilitate risk assessments of interdiciplinary teams (10%).
Provide strategic direction to process validation strategies for both internal and external (CMO) products (5%).
Support inspections and audits by third parties (e.g. regulatory agencies) and the timely closure of observations/audit items (5%).
Support innovation, continuous improvement and harmonization of workflows, quality systems and procedural guidances in the area of the validation of manufacturing processes (5%).
Maintain and develop expertise in process validation e.g. through trainings, literature review, participation in industry associations and workgroups and by adopting sensible and approved concepts (5%).
Contribute to QbD and PV communities of Practice and workshops (5%).
EDUCATION & EXPERIENCE REQUIREMENTS
University degree (BS/MS/PhD) in life sciences like biotechnology, biochemistry, pharmacy, process engineering or equivalent.
Minimum of 9-10 years of professional experience in industry environment of an internationally operating company recommended – ideally at least half of them in pharma industry.
Excellent and specialized knowledge and expertise in the area of Process Validation and QbD.
In-depth knowledge of and appropriate compliance with guidelines as well as Shire internal requirements.
In-depth experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.).
Experience in related disciplinary knowledge (eg. Tech Transfer, MFG Support, PD, AD, Statistics).
Excellent knowledge of risk assessment tools. Desired:
Excellent understanding of biotech products and processes
Excellent understanding of process development, characterization, and Product Launch for Biotech Products
KEY SKILLS & COMPETENCIES
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:Leadership Behaviors
Be Results Oriented
Be An Excellent Manager of Self and Others
Ability to lead global and interdisciplinary teams for medium and large projects.
Proven technical problem solving skills (especially in regard to regulatory demands vs. business – leads others to solve complex problems by exercising judgment and identification of innovative solutions).
Business acumen, strong strategic and process thinking.
High degree of internal/external customer orientation and strategic thinking.
Uncompromised dedication to quality.
Ability to take risk based decisions and to identify ‘must haves’, ‘preferences’ and ‘nice to haves’.
Cultural awareness when dealing with employees/partners/customers/regulators with different cultural background.
Strong written and verbal communication skills. English fluently both in spoken and written language
Quick perception, analytical and abstract reasoning, solution oriented thinking.
Demonstrated ability to work collaboratively with others and in a cross-functional team environment.
Personal attributes: integrity and trust, work ethic, courage, personal accountability for results, curiosity and passion for results.
Digital competencies, experience with project management tools.
Basic understanding of statistics and Six Sigma tools.
Ability to cope with pressure (flexibility in regard to changing demands)
COMPLEXITY & PROBLEM SOLVING
Takes decisions on:
Process validation strategies
Communication contents, paths and time points with internal and external stakeholdersWorks on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors.Resolve complex problems with critical business/program impact; strategically analyze internal and external issues and drive risk-based solutions and best practicesErroneous decisions will result in critical delays in schedules and/or unit operations and jeopardize overall project and department goals.
INTERNAL & EXTERNAL CONTACTS
PDTS PV Strategy teams (Vienna, CA and MA)
PDTS QbD Teams (CMA Methodology, QbD Systems, MQ, Program Management, Six Sigma & Statistics)
PDTS Product Lifecycle Team (CMC leads, Project Managers, Tech Transfer Project Managers), PDTS Process Development, PDTS Analytical Development, PDTS Technical Services Biologics & Plasma
P-One Project Management
Quality (Bio OPU Quality, , Quality Systems)
Manufacturing (OpU Biologics,)
Engineering Validation Biologics,
CMOs, Contract Development Organizations, Contract Testing Organizations
Industry Associations (e.g. BPOG, PDA, ISPE, etc.)
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.