Principal Process Chemist Manufacturing

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 someones 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 scaleup 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 ensuring alignment with regulatory expectations and company objectives.

• Develop and optimize CMCrelated 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 crossfunctionally on the development of synthesis purification formulation and aseptic filling processes including technology transfer scaleup validation and commercial launch activities.

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

• Prepare and review CMCrelated 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 scaleup 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 CMCrelated activities.

• Lead and participate in investigations to drive scientifically sound corrective and preventative actions (CAPAs). Apply creative problemsolving techniques to address immediate and longterm 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 selfstarter with the ability to work well both independently and in a team environment.

• Demonstrated technical problemsolving 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 interdepartmental 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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. Lantheus is an EVerify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable 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 .