|
Job Description The Associate Director, Process Validation, Manufacturing Science and Technology (MSAT) - Late-Stage Biologics is a key leadership role within the Commercial Manufacturing and Supply Chain (CMSC) organization and will be responsible for leading technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network. The role, based at our Seattle or Boston site, will partner with cross-functional teams internally and externally to ensure project deliverables supporting regulatory milestones are met and clinical and commercial supply to our patients is uninterrupted. Key Responsibilities:
Manage and influence internal and external cross-functional teams, setting strategic direction for late-stage development activities, leading to process performance qualification, associated CMC requirements and regulatory submissions. Manage and influence strategy for execution of process performance qualification (PPQ) and product life cycle. Manages, tracks and reports on readiness/execution status for PPQ / CPV activities and deliverables. Generates PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements. Implement consistent process qualification, process validation and CPV strategies. Support the establishment of network strategies for drug substance / drug product manufacturing and testing. Be an effective change agent and champion for continuous improvement and technical innovation within the BSMO network. Collaborate with risk management and program management functions to articulate technical risks and develop / manage mitigations. Liaise with tech leads from other programs to build collective biopharmaceutical operations knowledge. Engage across industry forums to identify best practices and improvement opportunities.
Minimal Requirements:
8+ years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience. Master's or doctoral degree in a science or engineering field. Experienced in process validation at commercial scale and bench scale. Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management. Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management. Advanced experience in a key technical leadership/management role in biologics process development, MSAT, and/or manufacturing. Previous leadership experience working in a highly matrixed environment. Experience with cGMP manufacturing, regulatory guidance and health authority inspections. Experience authoring/reviewing CMC product submissions and post-approval changes. Experience working with external manufacturing partners (CDMOs), suppliers, and service providers. Experience with operational excellence practices and root cause methodologies desirable. Ability to travel, domestically and internationally, up to 25%.
#LI-Hybrid Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
|
Vertex Pharmaceuticals Incorporated
Jan 11, 2025