Sr 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. 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 Sr. Project Manager is responsible for managing integrated development and Chemistry, Bioconjugation Development and manufacturing programs of key clients while ensuring alignment with Abzena’s functions, goals, and values. The Sr. Project Manager 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 their client relationships, the Sr. 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 Director of Program 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.
• Assist the PM Director in managing the PM group’s day to day tasks.
• 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.
• Excellent written and oral communication skills in both individual and group settings.
• Excellent analytical, negotiation and problem-solving skills
• Demonstrated ability to organize, lead, and execute a variety of assignments and action plans.
• Experience working with key stakeholders.
• A solid understanding of CMC development milestones from Phase 1 to commercialization.
• Knowledge of finance, accounting and managing budgets.
• Current industry knowledge of relevant regulations, guidelines, policies and CMC requirements.
  
  

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.