Project Manager

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 and 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.

About the role

The Program Manager is responsible for managing integrated development and Chemistry, Bioconjugation Development, and manufacturing programs for key clients while ensuring alignment with Abzena’s functions, goals, and values. The Program Manager II manages the planning, scheduling, and budgeting of CMC-related product/process development activities, including new product development, analytical methods development/validation, process improvements, and product characterization. In addition to managing key programs and client relationships, the Program Manager II will 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 Director of Project Management, Site Leadership, and Executive Leadership.
• Communicate all changes, plans, and goals to partnering departments and functions.
• Assist with risk and mitigation planning.
• Create kick-off meetings and Joint Team Meeting (JTM) content, agenda, and minutes.
• 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.
• Assist with development of others in the PM organization by providing coaching and guidance; may support OJT.
• Identify and support PM improvement initiatives.
• Provide support for the transfer of services between sites.
• 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.

Requirements

• MS in Life Science, Engineering, or related field.
• 4+ years project management experience, leading multiple complex projects/programs.
• 2+ years in CDMO.
• Experience in small molecules or antibody drug conjugates preferred.
• Broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
• 3+ years experience in a client-facing position.
• Experienced with Microsoft Project.
• Quick learner, independent, and accountable for their work/projects, and can quickly adapt to changes.
• Ability to work on site all 5 days.
• Ability to work with clients overseas in different time zones.