Manufacturing Operations Senior Manager – Biologics

Vertex Inc.•Seattle, WA

1d•$138,200 - $207,400•Hybrid

About The Position

The primary focus of the Manufacturing Operations Senior Manager, External Manufacturing role is to oversee Vertex’s critical Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of drug from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impacts. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located near Seattle, WA and/or be able to travel for extended periods of time as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Requirements

Strong manufacturing, quality and/or compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations.
Strong technical background in commercial drug substance manufacturing operations.
Solid project management skills and experience managing complex projects.
Strong verbal and written communication skills: ability to expresses one's self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
Strong leadership and an innate ability to collaborate and build relationships is critical.
Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
Flexibility to work shift hours required to cover critical process steps
Ability to travel, national and international, up to 30%
Represent Vertex as a leader when issues arise.
Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.).
6+ years of experience working in biopharmaceutical manufacturing and/or quality, or biopharmaceutical manufacturing sciences/process engineering/development.

Responsibilities

Function as the first/primary point of contact for all Vertex interests/activities at certain biologics Contract Development Manufacturing Organizations (CDMOs)
Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to success execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during batch manufacturing.
Leverage technical, quality and regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions.
Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations and deviations) to meet Vertex program requirements.
Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
Identify and escalate business-critical issues
Lead continuous improvement initiatives to affect timely resolution of supply issues.
Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
Live the Vertex values.