Senior Process Engineer

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. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

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.

Identify, assess, and execute projects to optimize existing and new processes, components, raw materials, and packaging in radiopharmaceutical manufacturing, pharmaceutical manufacturing, and final product packaging. Lead multi-functional teams to execute and deliver all aspects of assigned projects, including specification, conceptual development, selection, testing, and qualification.

Manage component, raw materials and packaging changes, replacements, and upgrades. Support Procurement with response to supply shortages. Identify and implement alternatives. Provide technical support and conduct investigations into product/process quality events.

An ideal candidate would have strong background in assessing and processing quality events inclusive of deviations, CAPA plans and actions, and investigations. Be able to use project management skills to organize and lead cross functional teams through data-based decision making for root cause investigations, technical transfers, or project improvements. Support larger projects collaborating across multiple teams. Strong partnership skills to build and maintain relationships.

Act as the company's subject matter expert for aseptic processes and components.

Essential Functions

• Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection. Evaluate opportunities and present projects to management for approval to implement changes.
• Manage qualifications and validations of processes spanning from product formulation/fill through packaging and final product release.
• Write and execute qualification protocols as the study director/engineer or working with/leading multi-functional teams to execute product and packaging projects to improve and optimize radiopharmaceutical manufacturing and packaging processes.
• Coordinate complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
• Manage, coordinate, and oversee development of product specification documents.
• Coordinate and lead team review of designs/deliverables and document decisions.
• 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. Propose and lead follow-up actions based on a risk-based approach.
• Support Supply Chain and Manufacturing in response to supply shortages and vendor material or component changes, or process optimizations. Lead the qualification activities required to implement alternative materials or changes to existing materials or process.
• Establish strong inter-departmental relationships act as a leader and a valuable technical resource to others. Provide support in the development, review and maintenance of operational SOPs. Present data and information as a technical subject matter expert to regulatory agencies.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take 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 and Experience and Education

• Degree in Engineering or related discipline or equivalent relevant industry experience.
• Requires a minimum of a Ph.D. degree and 4+ years relevant work experience or a M.S. degree and 6+ years relevant work experience or a B.S. degree and 10+ years relevant work experience.
• Scientific knowledge and experience in radiopharmaceutical process development and aseptic processes.
• Expertise with GMP documentation requirements and awareness of regulatory requirements in a CMC environment.

Other Requirements

• This individual should be a self-starter with the ability to work well both independently and in a team environment.
• Demonstrated skills in leading projects with an assigned team.
• Able to properly handle and minimize exposure to potentially hazardous chemical and/or radiological materials. Required to follow all safety procedures and use personal and protective equipment provided.
• Strong project management skills.
• Excellent organizational and time management skills.
• Extensive knowledge of various pharmaceutical unit operation principles and methodologies, particularly with aseptic fill and finish operations. Terminal sterilization knowledge a plus.
• Familiar with Code of Federal Regulations parts 210 and 211.
• Statistical Analysis/Process Modeling experience a plus.
• May supervise targeted group(s) or functional areas.
• Position may require work in radiation environments.

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.