Project Manager - Biologics

Project Manager - Biologics

Our Client:

Our client is a global leader in biologics product development services from discovery to commercial manufacturing for both novel and biosimilar drug therapies.

Job Summary:

The Project Manager is responsible for managing integrated development and Chemistry, Bioconjugation Development and manufacturing programs of key clients while ensuring alignment with Company’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 their client relationships, the Program Manager II will also support in 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.

• Complete ERP system activities, invoicing, cost control, revenue recognition, material tracking and procurement and assist with forecasting and change management activities.
• Document agreements and any changes to the statement of work.
• 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.

• Other related duties as assigned.
• Operate to the highest ethical and moral standards and participate effectively as a team player in all aspects of business and adhere to quality standards set by regulations and policies, procedures, and mission.

Qualifications/ Skills Required:

· MS in Life Science, Engineering or related field.

· PMP Certification preferred.

· 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 4 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 on 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.