Similar posts
CMC Program Manager
- Permanent
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)
- United States
This vacancy has now expired. Please see similar roles below...
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.
Related jobs
Highly Competitive
King of Prussia, USA
Proclinical is working with a pharmaceutical company to recruit for a Bench Scientist with a focus on Cell Banking. This is a temporary contract position based in King of Prussia, Pennsylvania.
US$25.00 - US$30.00 per hour
Cambridge, USA
Proclinical is seeking a dedicated and detail-oriented Senior Associate Scientist to support stability and specification tasks for siRNA drug substances and drug products.
US$35 - US$37 per hour
Norton, USA
Quality Control Analyst I -Contract - Norton, MA Proclinical is seeking a Quality Control Analyst I for a contract role in Norton, MA.
€55000 - €60000 per annum
Lyon, France
Proclinical is currently recruiting for a Quality Assurance to join a dedicated team. This is a permanent position based in Lyon, France.
£50000 - £55000 per annum
Surrey, England
Proclinical is currently recruiting for a Quality Assurance to join a dedicated team. This is a permanent position based in Surrey, United Kingdom.