Sr. Process Chemist - PET Drug Technology and Process Development

Lantheus is headquartered in Bedford, Massachusetts with offices in 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.

This position is site-based and requires a presence on-site three days per week.

Summary

The Senior process chemist will be responsible for supporting commercial and late-stage (phase 3) clinical products internally and to third party contract manufacturing organizations (CMOs) in the field of Positron Emission Tomography (PET) diagnostic imaging drugs and radioligand therapeutic drugs. 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 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

• Design and conduct process studies for clinical and commercial PET drug MFG process development.
• Critically evaluate data, determine appropriate conclusions and a plan of action in collaboration with internal and external stakeholders to develop GMP production processes.
• Provide project data and progress status updates to management.
• Work with cross-functional teams on the development of synthesis, purification, formulation and aseptic filling processes, including process transfer, scale-up, validation and launch activities.
• Support the preparation and review of written procedures, batch records, experimental protocols and reports, specifications and qualification/validation protocols.
• Prepare technical reports and documents, including SOPs and investigational reports.
• Conduct work according to best practices and, where appropriate, regulatory guidance, GMPs, established business processes and protocols, and applicable standard operating procedures
• Coordinate complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
• Manage Technical Transfer to CMOs or on-site process and material qualifications. Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
• Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term and future needs. Lead root-cause analysis investigations as a technical resource.
• Present data and information as a technical subject matter expert to regulatory agencies.
• Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
• Actively demonstrate the Lantheus values.
• Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

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 ....