Senior Chemist

Company: curium
Location: Noblesville
Posted on: May 27, 2023

Job Description:

About Curium

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 Quality Testing Engineer 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 Quality Testing Engineer will be responsible for working in collaboration with R&D, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch.

Essential Functions

• Support large cross-functional projects and project teams through Subject Matter Expert quality compliance guidance in process evaluation, design, and implementation of processes
• Provide cGMP, Regulatory, and Validation guidance in evaluation of new products within existing or new manufacturing equipment and clean room manufacturing areas
• Partner with R&D, Manufacturing, Quality, Engineering, and Maintenance to develop applicable SOP's, Batch Records, and Training Documents.
• Define requirements for and generate project validation plans
• Estimate quality and validation project activities to provide accurate cost and schedule targets
• Manage project quality assurance and validation activities and resources
• Generate, execute, and manage protocols
• Work collaboratively with Project Manager to quickly move projects from scoping to implementation
• Partner with Quality Leadership to ensure good quality and cGMP practices and their implementation in new product launch
• Provide input to forecast estimates for project related costs and general project task tracking for adherence to project milestone goals
• Generate and maintain quality risk assessments, including Failure Mode and Effects Analysis (FMEA)
• Provide support for and manage preparation of documentation for regulatory filings
  
  Requirements
  
  
  • Bachelor Degree required; in Engineering or Sciences preferred
  • Five years or more experience in quality assurance or validation roles in pharmaceutical manufacturing Experience in pharmaceuticals desired but willing to consider other development areas such as medical device experience
  • Strong project management and organizational skills, including ability to work independently and as a team member
  • Knowledge of regulatory requirements, and validation activities needed for manufacturing parenteral products
  • Verifiable working knowledge of cGMP regulations and guidelines.Application of cGMPs in an aseptic environment preferred
  • 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; experience with stage gate processes for ANDA submissions preferred
  • 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 thingsability to work "on the fly" in a dynamic setting
  • Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
  • Travel may be required up to 10% of the time
  • Lean and/or Six Sigma certification preferred
    
    Working Conditions:
    
    • 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 heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach with or without accommodation.
    • Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
    • Willingness to work in a team based environment.
    • Close attention to detail required.
    • May be required to stand or sit for long periods of time while performing duties. Must be able to stand 8+ hours a day.
    • Must possess good hand-eye coordination.
      
      Disclaimer
      
      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.
      
      Job Segment: Nuclear Engineering, Senior Quality Engineer, Medical Technologist, Six Sigma, Lean Six Sigma, Engineering, Healthcare, Management

Keywords: curium, Noblesville , Senior Chemist, Other , Noblesville, Indiana