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Job Description

This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Type 1 Diabetes (T1D) will be responsible for facilitating the cross-functional project teams executing our CMC and manufacturing strategies within the T1D 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, and milestone status associated with technical transfer (analytical/process), product manufacturing and testing, process validation, inspection readiness, capacity planning, product launch, lifecycle management and regulatory strategies and commitments. 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. 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.

RESPONSIBILITIES

• Partner closely with Strategic Product Leader, functional area leads to distill complex strategies and develop and maintain integrated CMSC program plans. Identify/communicate interdependencies as well as critical path activities for the project(s).
• Track and monitor key milestones and decision points and work with project team members to meet commitments and drive delivery of project objectives.
• Effectively communicate with senior leadership, team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects.
• Build and maintain effective program tools, including fully integrated CMSC program plan and timeline, key assumptions, milestones and decisions, risk register, after action review database, and cross-functional knowledge management materials.
• Identify meaningful KPIs and build program dashboard for key communications across all impacted functions.
• Assist in creation of lifecycle management plan, with a focus on strategic prioritization to ensure success in meeting patient needs, overcoming supply challenges and reducing COGS.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA) and/or PMP Certification preferred.
• Requires 10 years of experience in the biopharmaceutical industry. Previous experience in supply chain, technical operations and cell and gene therapy preferred.
• A minimum of 5 years of experience in project management of pharmaceutical products
• Experience interacting with and/or managing CDMOs/service providers.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment, proactively 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, OnePager, 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 plus.

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