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Principal Process Chemist (Manufacturing)
Job Category: Manufacturing & Production
Requisition Number: PRINC003537
Date:
Location: Billerica, MA, USA
Description
Lantheus is a leading company in medical imaging with headquarters in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden.
We are an entrepreneurial organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions to enhance patient care.
Our purpose and values guide our behaviors and contribute to our success.
We seek a diverse group of individuals with different viewpoints and skill sets to join our team.
Summary
The Principal Process Chemist will support commercial and clinical products internally and externally through cross-functional collaboration.
This role will be responsible for technology support, process development, process improvement, and transfer processes.
Key Responsibilities/Essential Functions
- Lead design and conduct radiochemistry experiments for clinical and commercial drug developments.
- Critically evaluate data and develop action plans to optimize GMP production processes.
- Support CMC strategy and execution, ensuring alignment with regulatory expectations and company objectives.
- Develop and optimize CMC-related documentation.
- Oversee analytical method development, validation, and stability programs.
- Work cross-functionally on process development and technology transfer.
- Manage CMC timelines and deliverables.
- Prepare and review written procedures and protocols.
- Lead process and analytical technology transfer to Contract Manufacturing Organizations (CMOs).
- Conduct risk assessments and implement mitigation strategies.
- Evaluate and resolve technical and quality issues.
- Support regulatory interactions and inspections.
- Present data and information to regulatory agencies.
Typical Minimum Skills and Experience and Education
- B.S. or M.S. degree in relevant scientific/technical disciplines.
- 8 years of work experience in the pharmaceutical industry.
- Previous experience working with radiopharmaceuticals and CMO management.
Other Requirements
- Self-starter with ability to work independently and in a team environment.
- Demonstrated technical problem-solving skills.
- Project management skills.
- Excellent organizational and time management skills.
- Excellent oral and written communication skills.
- Familiarity with regulatory guidelines and industry best practices.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
