What are the responsibilities and job description for the CMC Manager position at Actalent Services?
Job Title: CMC Specialist
Job Description
We are seeking a dedicated CMC Specialist to join our team. The successful candidate will qualify new sites and assist with stability studies, support technical transfer, and review, author, and manage CMC documents. This role involves site auditing, maintaining submission information in relevant CMC systems, and tracking timelines for specific projects and products. The CMC Specialist will manage and contribute to CMC-related projects, serve as a technical and scientific resource, and act as a CMC representative on core projects.
Responsibilities
- Qualify new sites and assist with stability studies
- Support technical transfer processes
- Review, author, and manage CMC documents
- Conduct site auditing and assist with qualification
- Maintain submission information in relevant CMC systems
- Track timelines for specific projects and products
- Manage and contribute to CMC-related projects and initiatives
- Serve as a technical and scientific resource for complex projects
- Act as a CMC representative on core projects, manage project activities, assess risks, and develop plans and strategies in accordance with regulatory, scientific, and technical criteria
Essential Skills
- Experience in CMC, tech transfer, validation, and quality assurance
- Proficiency with CMC systems, regulatory requirements, and GMP
- Experience authoring CMC regulatory sections, including INDs/CTAs
- Knowledge of PET Good Manufacturing Practice guidance and FDA regulations
- Understanding of US cGMP, ICH requirements, ISO9001, and US regulatory regulations
Additional Skills & Qualifications
- Bachelor's degree in a life science discipline with 5 years of quality assurance/technical experience in a pharmaceutical/life-science environment, or 3 years with a Master's degree
- 2 years of experience working in the pharmaceutical industry
- Strong experience in authoring CMC regulatory sections
Work Environment
The role requires onsite work three days a week, with some flexibility. The team consists of three members, offering significant decision-making power and influence on CMC decisions. The CMC Specialist will work closely with the analytical and regulatory teams.
Job Type: Full-time
Pay: $130,000.00 - $150,000.00 per year
Schedule:
- 8 hour shift
Work Location: In person
Salary : $130,000 - $150,000
