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

Job Description

This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager, Povetacicept (POVE) will be responsible for supporting the cross-functional project teams executing our CMC and manufacturing strategies within the Povetacicept program.  The position will work with the CMSC and CMC leads and interface directly with CDMOs and internal cross-functional teams. The position will track and report project scope/timeline/milestone status associated with technical transfer (analytical/process), regulatory strategies and commitments, product manufacturing, process validation, product testing, capacity planning, and external partner strategy. This is an exciting and visible role for a highly qualified and motivated individual.

The successful candidate will be detail-driven and have a proven track record in managing and driving project success within the biotech industry. We are seeking an individual with a technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, experience interacting with external manufacturers/service providers, and willingness to pivot as priorities change. Some knowledge and/or experience with cell / gene therapy methodologies and 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

• The project manager will work in close partnership with Program manager and other Project Managers to ensure seamless execution of the program and project-level deliverables of a fast-paced, high-priority program
• Be the PM point of contact for assigned workstreams. Work collaboratively and maintain tight alignment to drive integrated execution
• Partner closely with functional area leads and CDMOs to develop, maintain and actively monitor detailed integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s)
• Act as primary PM point of contact for assigned workstreams for internal stakeholders and external CDMOs
• Facilitating cross functional team meetings to ensure alignment; issue resolution by getting right stakeholders and decision makers in the room to facilitate prompt resolution and risk /mitigation management
• Track and monitor key milestones and decision points and work with project team members to drive delivery of project objectives
• Effectively communicate with internal and external team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects
• Organize and maintain team communications including meeting agendas, minutes, decision logs, 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 to ensure timely, transparent and open communication
• Assist in the creation and deployment of templates to manage team activities

QUALIFICATIONS

• Bachelor’s degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA preferred) or PMP
• A minimum of 5 years of experience in the biopharmaceutical industry.
• A minimum of 3 years of experience in CMC project management of biopharmaceutical products
• Understanding of CMC requirements for all phases of clinical development and commercialization
• Highly agile, be able to pivot quickly as priorities shift or as new workstreams emerge
• Ability to work independently, cross functionally and collaboratively in a team
• Excellent planning and organization skills with ability to prioritize
• Experience interacting with and/or managing CDMOs/service providers.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Previous experience in Biologics manufacturing including process validations/PPQ and commercialization preferred
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g. Smartsheet, ThinkCell, Power BI, etc.).
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Experience with regulatory submissions, manufacturing or QC/QA experience a plu