Posted on 30th January 2020
Principal Technical Transfer Engineer
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
The Principal Tech Transfer Engineer will work in a dynamic organization in the R&D Tech Transfer group for North America. This role has the responsibility for supporting and implementing projects related to Curium’s business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. This role will help support activities associated with BD&L, M&A, PMO, and CMO activities. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The Principal Tech Transfer Engineer will be responsible for working in collaboration with project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch.
- Support large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes
- Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment · Experience preparing documents related to CMC aspects for regulatory submission.
- Provide Aseptic Manufacturing expertise and guidance of evaluation and design of new processes and equipment
- Bachelor’s degree in Chemical Engineering or Chemistry; Master’s preferred
- Ten years or more of relevant experience with majority in cGMP environments
- Significant experience in optimization of processes, including establishment of process KPI’s
- Experience in pharmaceuticals, experience with medical isotopes preferred
- Strong project management and organizational skills, including ability to work independently and as a team member
- Experience with radiation safety programs (preferred but not required)
- Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products, including lyophilization preferred
- Knowledge of current industry practices and technologies
- Familiar with project management tools and best practices
- Experience applying formal Root Cause Analysis and problem- solving methodologies
- Proven ability in setting priorities and organizing work to meet deadlines
- Technical understanding of the pharmaceutical development process from concept to launch
- Proven experience within complex multi-discipline project teams in a highly regulated environment
- Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments
- Ability to react to problems and lead the team to develop solutions while communicating effectively to project leadership and stakeholders
- Ability to maintain collaboration in a results-driven environment
- Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting
- Proficient with Microsoft Office (Excel, PowerPoint, SharePoint, Word), experience with MS Project and Visio preferred
- Lean and/or Six Sigma certification preferred
- Standard office environment, coupled with approximately 50% time in clean room, radio-pharmaceutical manufacturing, and laboratory environments.
- Must be willing to wear a variety of personal protective equipment.
- Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.