Senior Scientist Analytical Development and CMC Small Molecule Expert

2 weeks ago

North Billerica Billerica MA USA, United States Lantheus Medical Imaging Inc Full time
Job Summary

Lantheus Medical Imaging Inc is seeking a highly skilled Senior Scientist to join our team in Analytical Development and CMC Small Molecule. As a key member of our organization, you will be responsible for providing technical support to manufacturing, QC laboratories, and the Quality Organization to resolve test issues, conduct OOT/OOS investigations, and drive innovation.

Key Responsibilities:

  • Work independently to achieve personal objectives while adapting to evolving organizational needs.
  • Provide technical guidance and support to manufacturing, QC laboratories, and the Quality Organization to resolve test issues, conduct OOT/OOS investigations, and drive innovation.
  • Participate in and contribute to projects across organizational units, including R&D and MTD method development, method validations, technology transfer, and post-NDA process changes.
  • Maintain laboratory notebook, record keeping, and laboratory safety in accordance with industry GMPs and LMI procedure.
  • Provide Quality and Technical support for post-NDA initiatives and new product launches.
  • Support key Quality Committees, such as Compendial Change Control, Document Change Control, and Stability Review.
  • Provide technical input during regulatory and corporate inspections and audits.
  • Maintain and grow personal scientific, regulatory, and compendial expertise, and work with lab management to develop organizational capabilities.
  • Exhibit high personal standards for Safety, Quality, Performance, Personal Development, and Core Behaviors.
  • Serve as a technical writer to support MTD and QC organization for internal and external communications, including regulatory submissions and responses.

Requirements:

  • D./M.S./B.S. /B.A. in Chemistry, Pharmaceutics with a fundamental understanding of analytical chemistry and pharmaceutical process development.
  • Requires a minimum of a Ph.D. degree and 0 – 2 years relevant work experience or a M.S. degree and 3+ years relevant work experience or a B.S. degree and 6+ years relevant work experience in the pharmaceutical industry.
  • Experience in Analytical Chemistry is highly preferred. Three (3) to five (5) years' experience in laboratory operations in a pharmaceutical CMC environment, experienced in chromatography data systems.
  • Experience in analytical QC or R&D lab using HPLC/GC analysis and empower/LIMS, is strongly preferred.
  • Excellent verbal and written communication skills.
  • Demonstrate working understanding of laboratory operations and practices strong organizational and/or project management skills.
  • Strong analytical development and problem-solving skills.
  • This position requires flexibility with changing priorities.

Additional Requirements:

  • Possess enhanced technical skills and command of analytical laboratory instrumentation and equipment. Familiarity with HPLC-UV, HPLC-CAD, GC, GC-MS, KF, and wet chemistry.
  • Travel may be required.

Lantheus Medical Imaging Inc is an equal employment opportunity and non-discrimination employer 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 Medical Imaging Inc is an E-Verify Employer in the United States. Lantheus Medical Imaging Inc will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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 Medical Imaging Inc Talent Acquisition team

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