Lead Process Chemist in Manufacturing Science

2 weeks ago

North Billerica, United States Lantheus Medical Imaging Inc Full time
Position Overview

Lantheus Medical Imaging Inc. is a leader in the field of medical diagnostics, dedicated to enhancing patient care through innovative solutions. Our organization is characterized by its entrepreneurial spirit and commitment to excellence, fostering a collaborative environment where every team member plays a vital role in our success.

The Senior Process Chemist will play a crucial role in supporting both commercial and clinical products, collaborating with third-party contract manufacturing organizations (CMOs) in the medical imaging and therapeutics sectors. This position requires a strong focus on technology support, process development, and process enhancement, including planning, scale-up, and development studies.

Key Responsibilities:

  • Design and execute radiochemistry experiments for the development of clinical and commercial pharmaceuticals.
  • Analyze data critically to draw conclusions and formulate action plans in collaboration with internal and external partners to establish GMP production processes.
  • Provide updates on project data and progress to management.
  • Collaborate with cross-functional teams on the development of synthesis, purification, formulation, and aseptic filling processes, including process transfer and validation activities.
  • Assist in the preparation and review of written procedures, batch records, experimental protocols, and technical reports.
  • Conduct work in accordance with best practices, regulatory guidance, and established protocols.
  • Manage complex projects to meet established timelines while ensuring manufacturing continuity.
  • Oversee technical transfers to CMOs and manage validation protocols, acting as the study director or collaborating with the Validation department.
  • Lead investigations to implement scientifically sound corrective and preventative actions, utilizing creative problem-solving techniques.
  • Present data as a technical expert to regulatory agencies.
  • Promote a culture of safety and adhere to best safety practices.
  • Demonstrate the core values of Lantheus in all professional interactions.

Qualifications:

  • B.S. or M.S. in relevant scientific or technical disciplines; advanced degrees (e.g., PhD) or technological certifications are preferred.
  • Over 10 years of experience in the pharmaceutical or medical device industry, with at least 5 years in manufacturing process development and technical transfer.
  • Experience with aseptically filled drug products, medical devices, radiopharmaceuticals, and CMO management is highly desirable.

Additional Requirements:

  • Self-starter with the ability to work independently and collaboratively.
  • Strong technical problem-solving skills and experience with root cause analysis.
  • Proficient project management skills.
  • Excellent organizational and time management abilities.
  • Strong oral and written communication skills, with the ability to produce and review technical documents.
  • Ability to establish strong inter-departmental relationships and serve as a valuable technical resource.
  • Familiarity with regulatory standards and experience in drafting regulatory filing sections.
  • Willingness to travel as needed.

Lantheus is committed to fostering an inclusive workplace that values diversity and equal opportunity for all employees and applicants.

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