Global Project Manager

Overview

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Global Project Manager is responsible for managing integrated development and manufacturing activities for protein, chemistry and bioconjugation programs of key clients while ensuring alignment with Abzena’s functions, goals, and values. In this role the Global Project Manager will serve as the primary point of contact for clients with support from site level project and program managers. The Global Project Manager manages the planning, scheduling, and budgeting of CMC-related product/process development activities, including new product development, analytical methods development/qualification/validation, process improvements, and product characterization. In addition to managing key programs and their client relationships, the Global Project Manager will also support the development of the PM organization through coaching and guidance.

Responsibilities

• Create project plans to meet client needs.
• Track, adjust and report milestone deliverables to clients, as well as internally to the VP of Program Management, Site Leadership, and Executive Leadership.
• Communicate all changes, plans, and goals to partnering departments and functions.
• Identify project risks, development and manage mitigation plans.
• Create kick-off meeting and Joint Team Meeting (JTM) content, agenda, and minutes.
• Provide support for the transfer of services between sites.
• Document agreements and any changes to the statement of work.
• Complete ERP system activities, invoicing, cost control, revenue recognition, material tracking and procurement and assist with forecasting and change management activities.
• Provide support with project budgets, including but not limited to: review cost/price analysis, pressure test and align assumptions in the forecast, ensuring transparency and communication of the approved plan and funding status of activities.
• Identify and support PM improvement initiatives.
• Provide support for internal governance processes.
• Assist with the development of others in the PM organization by providing coaching and guidance; may support OJT.
• Maintain positive personnel and client relationships and communication.
• Operate to the highest ethical and moral standards and participate effectively as a team player in all aspects of Abzena's business and adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Other related duties as assigned.

Qualifications

• MS in Life Science, Engineering, or related field.
• 5+ years CMC experience in small molecules, biologics, or antibody drug conjugates and broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
• 5+ years project management experience, leading multiple complex projects/programs.
• Minimum of 3 years' experience in a client-facing position.
• Knowledge of project management best practices and proficiency with supporting project management tools.
• Demonstrated ability to organize, lead, and execute a variety of assignments and action plans.
• Excellent written and oral communication skills in both individual and group settings.
• Excellent analytical, negotiation and critical thinking skills
• Experience collaborating with key stakeholders.
• A solid understanding of CMC development milestones from Phase 1 to commercialization.
• Current industry knowledge of relevant regulations, guidelines, policies, and CMC requirements.
• Knowledge of finance, accounting and managing budgets.