Commercial Manufacturing and Supply Chain Senior Project Manager (Late Stage Biologics)

Job Description

This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible for supporting the cross-functional project teams executing our development CMC and CMSC strategies within the POVE program.  The position will partner with the Program Management, CMC functional leads and interface directly with CDMOs to manage cross-functional planning and execution of late-stage development program through commercialization. This role will provide operational expertise as part of program management function to lead strategic planning and drive integrated execution for Biologics drug substance manufacturing, process validations, BLA filing and launch readiness. He/she will partner with cross-functional team to lead development and implementation of integrated plans addressing program scope, timelines, budget, communications, risks and change management, ensuring cross-functional alignment. This is an exciting and visible role for a highly qualified and motivated individual, involving strong cross-functional engagement with stakeholders

The successful candidate will be detail-driven and have a proven track record in managing and driving CMC strategies and project success within the biotech industry. We are seeking an individual with a Biologics technical background, solid working knowledge of GMPs, experience interacting with external manufacturers/service providers, understanding of the drug substance development pathway through validations, BLA submissions and launch/commercialization, and willingness to pivot as program priorities change. A strong understanding of risk management will be an asset.  The successful candidate will have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.

This is a Boston based, hybrid position requiring 3 day/week onsite.

RESPONSIBILITIES

• Partner closely with POVE program management lead, functional area lead and CDMO to lead the planning and execution of late-stage development program through commercialization for assigned Biologics drug substance workstream
• Provide operational expertise as part of the Program Management function. This includes working with CMC development, MS&T and key stakeholders to develop, actively manage and maintain high-quality integrated plans addressing scope, timelines and risks related to manufacturing, process characterization, validation, testing, BLA and launch readiness. Identify/communicate interdependencies and critical path activities for the project(s)
• Track and monitor key milestones and decision points and work with project team members to drive delivery of project objectives.
• Co-lead internal and external sub-team meetings to drive execution per agreed plan and maintain decisions and actions for tracking to completion
• Effectively communicate with internal and external team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with workstreams/projects
• Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies using Program Management preferred technologies
• Update and maintain project status tools, such as a project action log, risk register, budget and reporting dashboards
• Build and maintain tools to monitor and communicate program progress in line with program communication requirements
• Assist in the creation and deployment of templates to manage team activities
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
• Ensure effective, proactive and open communications to achieve transparency and clarity of program goals, progress and issues

QUALIFICATIONS

• Bachelor’s and/or advanced degree (PhD, MS, and/or PMP Certification) in engineering, life sciences or related field.
• A minimum of 8 years of experience in the biopharmaceutical industry
• Previous experience in Biologics drug substance manufacturing including process validations/PPQ and commercialization
• A minimum of 3 years of experience in project management of biopharmaceutical products
• Experience managing external CDMOs/service providers.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g. Smartsheet, ThinkCell, OfficeTimeline Pro+