Sr. Scientist CMC Analytical Development

Company: Lantheus
Location: Billerica
Posted on: October 19, 2024

Job Description:

Description
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.
Summary of roleThis Billerica based position reports to Senior Director of Manufacturing Technology & Development (MT&D). This is a small molecule & radiopharmaceutical focus analytical development role supporting new and improved analytical methods and commercial processes, physico/radiochemical characterizations in support of late phase pharmaceutical development, technology transfer to Contract Manufacturing Organizations (CMO), and authoring CMC non-clinical dossier sections.
Key Responsibilities/Essential Functions

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• Work with minimal supervision to achieve personal objectives, within Lantheus SOPs and governing regulations, while realigning to meet evolving organizational needs.
  
• Ensure integrity, accuracy, and compliance of analytical data in accordance with FDA, EMA, and other governmental regulatory standards. Prepare and review CMC analytical sections of regulatory submissions (NDA, NDS, MAA) and respond to regulatory requests for information.
  
• Provide technical input during regulatory and corporate inspections and audits.
  
• Completes work in a resourceful, self-sufficient manner and is able to develop creative solutions to achieve business goals.
  
• Provide technical guidance in analytical support to manufacturing, CMO-QC laboratories, and to the Quality organization to resolve test issues, conduct root-cause investigations, identify and improve problematic methods, and drive innovation.
  
• Participate in and contributes to projects of diverse nature across organizational units, such as: R&D and MT&D method development, method validations, technology transfers, and post-NDA process changes.
  
• Authors technical transfer protocols and ensure acquired results are collected and documented according to cGMPs; Assists in completion of close-out reports and appropriate Change Controls.
  
• Maintains laboratory notebook, record keeping, and laboratory safety in accordance with common industry GMPs and Lantheus' procedures.
  
• Maintain and grow personal scientific, regulatory and compendial expertise, and work with management to develop organizational capabilities.
  
• Shows the ability and willingness to continually enhance functional and technical expertise. Assesses own strengths/ needs and learns from experience and feedback in order to continually enhance the level of functional and technical expertise. Takes action on developmental opportunities.
  
• Keeps abreast of science, literature developments within field, program direction and current business issues.
  
• 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 & environmental hazards.
  
• Actively demonstrates the Lantheus core values of 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
  
  Basic Qualifications
  
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  • D./M.S./B.S./B.A. in Chemistry, Pharmaceutics, Engineering, Mathematics (or equivalent) with a deep understanding of the technical aspects of analytical chemistry and pharmaceutical process development, and a fundamental awareness of the roles of other pharmaceutical functionalities (including Regulatory, Compliance, Quality and Supply Chain).
    
  • Requires a minimum of a Ph.D. degree and 2+ years relevant work experience or a M.S. degree and 3+ years relevant work experience or a B.S./B.A. degree and 6+ years relevant work experience.
    
  • Experience in Analytical Chemistry is highly preferred with three (3) to five (5) years' experience in laboratory operations in a pharmaceutical CMC environment and experienced in chromatography data systems.
    
  • Experience in common and radiopharmaceutical separation and detection techniques (including HPLC-RC/UV, GC-FID, radioisotope detectors) in QC or development labs, is strongly preferred.
    
  • Demonstrate working understanding of laboratory operations and practices strong organizational and/or project management skills.
    
  • Strong analytical development and problem-solving skills.
    
  • Excellent verbal and written communication skills
    
    Other Requirements
    
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    • Mastery of regulatory requirements for job and extended group functions, expertise with regulatory requirements for pharmaceutical development.
      
    • Exceptional knowledge of scientific field of specialization.
      
    • Demonstrated skills in leading projects with an assigned team.
      
    • Able to properly handle and minimize exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
      
    • Demonstrated ability to effectively communicate ideas and information, both in oral and written form.
      
    • May supervise targeted group(s) or functional areas.
      
    • Travel (including international) is highly anticipated
      
      
      

Keywords: Lantheus, Revere , Sr. Scientist CMC Analytical Development, Other , Billerica, Massachusetts