CMC Program Manager job in Bristol, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)

Location: United States

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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.