Pharmaceutical Process Development Expert

7 days ago


Maryland Heights, Missouri, United States Curium Live Forward Full time

About the Role

Curium Live Forward is seeking a highly skilled Development Chemist to join our team. As a key member of our R&D department, you will play a critical role in the development of new products through chemical synthesis, labeling, purification, and other processes.

Key Responsibilities

  • Support R&D initiatives and project teams by developing and implementing robust drug product formulations and processes.
  • Contribute to the lifecycle management of existing products, ensuring compliance with regulatory requirements.
  • Design, synthesize, purify, and characterize drug candidates using a risk-based approach to drug development.
  • Design and execute experiments to support process design and expand the development space for successful tech transfer of processes.
  • Interpret chromatography spectra and other analytical data to inform process development decisions.
  • Collaborate with research and operation-focused functional teams, including manufacturing and quality functions.
  • Prepare scientific documents, including batch records, laboratory notebooks, summary reports, and other documents in support of CMC aspects for regulatory submissions.
  • Perform other duties as assigned, ensuring operational compliance with US and international regulatory agencies and guidelines.

Requirements

  • Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or a related field.
  • Minimum of three years of relevant work experience, preferably in pharmaceutical drug development or process chemistry.
  • Understanding of pharmaceutical drug development or process chemistry is desired, with a strong familiarity with cGMP, FDA, USP, NRC, and ICH guidelines.
  • Effective communication and collaboration skills, with the ability to work cross-functionally within and outside the organization.
  • Behavioral requirements for success in this position include self-motivation, a strong work ethic, excellent written and verbal communication skills, and a willingness to learn new things.

Working Conditions

  • Ability to work in a plant producing radioactive materials, with a willingness to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Responsibilities include lifting up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, and physically negotiating stairs and evacuation ladders with or without accommodation.
  • Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
  • May be required to sit or stand for long periods of 8+ hours a day while performing duties.
  • Must possess good hand-eye coordination and close attention to detail.
  • Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic materials, dust, dirt, odors, and irritants.
  • Willingness to complete safety training within allotted timeframes and work in a team-based environment.
  • Ability to work outside of regular work hours, including off-shift, weekend, and holiday work as business needs require.


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