Associate Director, MSAT

Description

About Lantheus

Lantheus (NASDAQ : LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands.

This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey, requires a presence on-site four days per week, and is and open to applicants authorized to work for any employer within the United States.

Responsibilities

The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. 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 pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics' procedures, and that processes are defined 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.

Additionally, this role :

• Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process / 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 product and manufacturing processes of parenteral dosage forms.
• 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 the Internal and CDMO 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 business growth.
• Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from 'sending' sites for an optimized manufacturing process.
• Leads, motivates, mentors, and develops team members to exceed and meet 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.
• Leads a team of engineers / scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• 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 company values.

Basic Qualifications

Preferred Qualifications

Core Values

The ideal candidate will embody Lantheus core values :

The pay range for this position is between $151,700 and $227,600 annually.

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 10, 2025.

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. Lantheus is an E-Verify Employer.

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 .

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.