Associate Director, MSAT

Associate Director, MSAT

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 remote.

Summary of Role

The Associate Director, MSAT, acts as a technology development and transfer lead in the Manufacturing Technology and Development (MT&D) organization at Lantheus. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable PET radiopharmaceutical finished products. This role will be a principal expert and process owner for the end-to-end manufacturing process for injectable PET radiopharmaceutical finished products at Lantheus. Ensures processes are designed and validated per applicable cGMPs, including USP 823 and 21 CFR 212 as well as Lantheus procedures, and that processes are defined in a manner consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating / maintaining associated tech development transfer business processes.

Key Responsibilities / Essential Functions

Leads technology development and transfer projects for key lifecycle injectable PET radiopharmaceutical products, including the establishment of the process and / or parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.

Leads a team of engineers / scientists to execute the development, characterization, optimization and troubleshooting of manufacturing processes of PET radiopharmaceutical products.

Leads a team of engineers / scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS).

Designs, prepares, and reviews technology transfer protocols, methods / processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders.

Partners with R&PD as well as the Internal and CMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.

Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Lantheus' business growth. Work cross-functionally with the BD team to assess product demand and network capacity and implement or manage process improvement efforts or new site activations to increase capacity or meet product demand.

Partners with site operations to provide a radiopharmaceutical manufacturing process that is sustainable for future product supply. Partners with existing sites in the networks to incorporate lessons learned from 'sending' sites for an optimized manufacturing process.

Leads, motivates, mentors, and develops team members to exceed MT&D and company goals.

Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.

Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.

Requires approximately ~20% travel.

Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.

Actively demonstrates Lantheus' values.

Basic Qualifications

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.

10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, 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

Subject matter expert (SME) in PET radiochemistry and radiotracer development, including automated synthesis / production and analytical method development. Experience with the validation of radiotracer production following the implementation of improvement or development activities.

Subject matter expert (SME) in PET radiopharmaceutical production operations, including CMO / PMF management. Experience with coordinating and translating radiopharmaceutical projects from the development phase to implementation and subsequent production phase.

Subject matter expert (SME) in parenteral operations : aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes.

Experience with the regulatory requirements surrounding clinical and commercial PET radiopharmaceutical manufacturing (USP 823 & 21 CFR 212).

Track record of successful regulatory filings and demonstrated success with CMC (IND Module 3) writing and editing.

Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.

Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes.

Ability to work within and lead different and cross-functional technical teams.

Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing. Experience with working within a quality management system as it relates to clinical and commercial PET radiopharmaceutical production.

Experience with project management systems and tools is preferred.

Excellent organizational skills and the ability to successfully manage a multitude of technical projects.

Ability to work in a prompt, complex and changing environment.

Demonstrated management, sociable and ability to work in team. Strong mentor, with excellent people development skills and track record.

Proactive mindset with strong leadership, facilitation, teamwork, and influence management / negotiation skills.

Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.

Understanding of FDA and / or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired.

Experience working with external partners is highly desirable.

Ability to work independently in decision-making and resolution of program obstacles and conflicts.

Keen insight, independent judgment and tactful discretion are required.

Ability to function autonomously, with an appreciation of detail while being cognizant of "the big picture".

Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Lantheus to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.

Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Lantheus and CMO locations.

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.