Sr Scientist II - PET Manufacturing Technical Support

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 of role

We are seeking a qualified candidate to provide technical support for daily Commercial and Clinical Operations as well as participate in validation activities, PET CMO (Contract Manufacturing Organization) qualification initiatives, troubleshooting, and continuous improvement endeavors within a growing PMF (PET Manufacturing Facility) network with an expanding product portfolio. Role will provide leadership and technical expertise - both internally and externally - to cross-functional teams as well as support field execution with focus on compliance with industry regulations, quality standards, and regulatory frameworks.

Key Responsibilities/Essential Functions

• Represents Technical Operations for commercial and clinical projects with Quality and R&D, assessing adequacy of manufacturing process according to clinical phases, providing technical insight to risk assessments for new products, and reviews technology transfer plans at PET CMO sites to assess if appropriate for the product & process. Interfaces with clinical suppliers for new processes, quality issues and process improvements for assigned projects.
• Provides support to Regulatory Affairs for product IND and new NDA submissions and supports inspection readiness, participate in regulatory agency inspections and provide audit support, as required.
• Follows procedures to support intellectual property protection.
• Maintains technical oversight of PET CMOs sites to ensure regulatory, procedural, standards, and contractual compliance. Includes: leading technical visits to PET sites including due diligence and technical audits; support of investigations, root cause analysis and generation of CAPA; assessment of manufacturing process changes to ensure that quality attributes are maintained (e.g. change control); author/review Annual Product Reviews; and drives continuous improvement projects relating to Product Quality.
• Provides technical expertise to weekly/monthly/quarterly PET CMO and Supplier Review meetings. Works with partner groups to develop and present metrics relating to PET CMOs and suppliers.
• Represents Technical Operations with Quality, Commercial, R&D, and Supply Chain for PET manufacturing, and builds strong working relationships to contribute to a high-performance culture. Collaborates well with the cross-functional team and work efficiently in a team environment. Communicate effectively with management, stakeholders, regulatory agencies and vendors.
• Provides ongoing coaching and performance management to project team. May be responsible for planning, assigning, directing, and evaluating the work of other Scientists, Engineers, and various team members. Improves team's capabilities and performance as well as maintains accountability for performance and behavior.
• Actively demonstrates the Lantheus values of accountability, collaboration, customer service, quality, efficiency and safety.

Basic Qualifications

• Bachelor's or Master's degree in science or engineering with > 7 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP; or PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP. PET manufacturing and analytical experience is desirable.
• Demonstrated leadership and managerial skills. Work cross-functionally with a team of internal scientists and engineers; manages external vendors to ensure compliance to project timelines, cGMPs and on-going manufacturing operations.

Other Requirements

• Exceptional knowledge of scientific field of specialization.
• Ability to recommend, judge, and make good decisions in complex situations.
• Demonstrated ability to manage major to complex projects efficiently; experience using project management tools is desired.
• Strong organizational, presentation, and communication skills, both written and verbal.
• Ability to effectively write technical documents, including test plans, protocols, and reports.
• Experience in a fast-paced PET production environment with the ability to troubleshoot and resolve technical issues quickly.
• Travel (including international, overnight, and weekend) may be required, approximately 10-20%

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify 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 talentacquisition@lantheus.com.