Principal Scientist CMC Process Improvement

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. 

Job Summary

Provides extensive scientific expertise, strategic leadership, and deep knowledge of regulatory frameworks in radiopharmaceuticals. This senior-level role requires a well-rounded individual who can drive drug process development and manufacturing strategies, lead cross-functional teams, and ensure compliance with USA government regulations related to radiopharmaceuticals.

As a Principal CMC Contributor, you will play a key role in the development and execution of strategies that shape the future of radiopharmaceutical products, from early-phase development to commercialization.

Essential Functions

· Lead and contribute to the scientific understanding and technical strategy of drug development, particularly in the radiopharmaceutical sector. Provide deep expertise in chemistry, manufacturing, and controls to support the development of new radiopharmaceutical products. Demonstrates knowledge and expertise in applying all aspects of advanced chemistry and engineering principles to the design and development of both current and new radiopharmaceuticals.

· Leverage extensive knowledge of U.S. FDA regulations, including 21 CFR Parts 210, 211 and 212, as well as other government regulations specific to radiopharmaceuticals (e.g., cGMP, IND, NDA) to ensure compliance during the drug development lifecycle. Navigate regulatory submissions and provide strategic advice for regulatory approvals.

· Lead and mentor cross-functional teams, including scientists, regulatory experts, quality control, and production teams. Guide team members in problem-solving and strategy execution while fostering a collaborative and high-performance environment.

· Lead efforts in the development of scalable, efficient, and robust manufacturing processes for radiopharmaceuticals. Drive the design, optimization, and validation of manufacturing processes, from preclinical through clinical and commercial phases.

· Define the strategic direction of CMC activities, including timelines, budgets, and resource allocation, in alignment with organizational objectives. Provide leadership on high-level CMC strategy, overseeing technical risk management and ensuring alignment with company goals.

· Ensure the preparation and timely submission of regulatory documents, including CTD modules, CMC sections for IND/NDA/BLA submissions, and other regulatory filings. Provide scientific and technical writing expertise for regulatory documentation.

· Serve as a key liaison between CMC, clinical development, regulatory affairs, quality assurance, and manufacturing teams to ensure effective and clear communication across all areas involved in product development.

· Maintains state-of-the-art knowledge of in the field of radiopharmaceutical development and contribute thought leadership within the organization. Promote support of intellectual property protection. May be responsible for preparing and defending patent disclosures and applications.

· Actively promotes safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

· Actively demonstrates the Lantheus values of Helping people be their best; Respect one another and act as one; Learn, adapt, and win; Know someone’s health is in our hands; and Own the solution and make it happen.

Typical Minimum Skills, Experience and Education

· Ph.D./M.S./B.S. Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field (or equivalent industry experience).

· In-depth understanding of U.S. FDA regulations and guidelines for radiopharmaceuticals, including experience with IND, NDA, and BLA submissions. Knowledge of international regulatory requirements (EMA, ICH) is a plus.

· At least 10+ years of