Principal Process Chemist (Manufacturing)

Job Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary

The principal process chemist will be responsible for supporting commercial and clinical products internally and to third party contract manufacturing organizations (CMOs) in the field of medical imaging and therapeutics. Working cross functionally, the role will be accountable for the technology support, process development, process improvement and transfer processes including planning, process scale-up and development studies, gap assessments, and equipment / process qualification. Following commercialization of finished products, the role is responsible for managing improvement projects and supporting evaluation and resolution of technical and quality issues to ensure supply of commercial products. in the Manufacturing Technology and Development (MT&D) organization at Lantheus.

Key Responsibilities/Essential Functions

Lead design and conduct radiochemistry experiments for clinical and commercial drug developments.

Critically evaluate data, determine appropriate conclusions, and develop an action plan in collaboration with internal and external stakeholders to optimize GMP production processes.

Support CMC strategy and execution, ensuring alignment with regulatory expectations and company objectives.

Develop and optimize CMC-related documentation, including CMC sections of regulatory filings (IND, NDA, BLA, DMFs, etc.), ensuring compliance with FDA, EMA, and other regulatory agencies.

Oversee analytical method development, validation, and stability programs to support drug substance and drug product manufacturing.

Work cross-functionally on the development of synthesis, purification, formulation, and aseptic filling processes, including technology transfer, scale-up, validation, and commercial launch activities.

Manage CMC timelines and deliverables, ensuring smooth progression from early development to commercial manufacturing.

Prepare and review CMC-related written procedures, batch records, experimental protocols/reports, specifications, and qualification/validation protocols to ensure compliance with regulatory and GMP guidelines.

Lead process and analytical technology transfer to CMOs, working closely with external partners to support scale-up and manufacturing readiness.

Conduct risk assessments and implement mitigation strategies for process robustness and product quality.

Ensure adherence to regulatory guidelines (e.g., FDA, EMA, ICH) and industry best practices in all CMC-related activities.

Lead and participate in investigations to drive scientifically sound corrective and preventative actions (CAPAs). Apply creative problem-solving techniques to address immediate and long-term technical challenges.

Support regulatory interactions and inspections, acting as a subject matter expert (SME) for CMC topics.

Present data and information to regulatory agencies, demonstrating a deep understanding of radiopharmaceutical product development and manufacturing.

Actively promote safety and compliance, demonstrating best practices in a GMP environment.

Write and manage actions for change controls in the Quality Management System (QMS) as applicable for technology transfers and CMC activities.

Typical Minimum Skills and Experience and Education

Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required.

8+ years of work experience within pharmaceutical or medical device industry, 5+ years of Radiopharmaceutical manufacturing process development, process validation, and technical transfer, within a matrixed pharmaceutical, medical device, or biotechnology organization.

Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CMO management strongly preferred.

Other Requirements

This individual should be a self-starter with the ability to work well both independently and in a team environment.

Demonstrated technical problem-solving skills with root cause analysis tools.

Direct experience with project management skills.

Excellent organizational and time management skills.

Excellent oral & written communication skills. Demonstrated ability to write and review technical documents and develop and present technical presentation materials.

Establishes strong inter-departmental relationships and is viewed as a leader and a valuable technical resource to others.

Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies

Familiar with Code of Federal Regulations parts 210 and 211 and supporting regulatory inspections.

Experience in drafting and reviewing of Chemistry, Manufacturing and Controls regulatory filing sections.

Ability to support travel 30%.

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered 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 other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at

Full-time