CMC Program Manager

CMC Program Manager - Permanent - Onsite

Proclinical is seeking a CMC Program Manager to join a cutting-edge manufacturing company. This is a permanent role located in Bristol, PA.

Skills & Requirements:

• MS in Life Science, Engineering, or related field.
• 5+ years of 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 of project management experience, leading multiple complex projects/programs
• Minimum of 3 years' experience in a client-facing environment
• Knowledge of project management best practices and proficiency with supporting project management tools.
• 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.
• Must be eligible to work in the US.

The CMC Program Manager will:

• 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 the 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

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.