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.

Pay and Benefits

The pay range for this position is $130000.00 - $150000.00/yr.

I have Lantheus benefits that I can send any person that is interested. They have health, dental, vision, 401k, and holiday and vacation PTO.

Workplace Type

This is a hybrid position in North Billerica,MA.

Application Deadline

This position is anticipated to close on Feb 20, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $130,000 - $150,000