Senior Process Chemist, Manufacturing Science

3 weeks ago

North Billerica, United States Lantheus Medical Imaging Inc Full time
Job DescriptionJob Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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.

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.

The Senior process chemist will be responsible for supporting commercial and clinical products internally and to third party contract manufacturing organizations (CMOs) in the field of medical imaging and therapeutics. Working cross functionally, the role will be accountable for the technology support, process development, process improvement and transfer processes including planning, process scale-up and development studies, gap assessments, and equipment / process qualification. Following commercialization of finished products, the role is responsible for managing improvement projects and supporting evaluation and resolution of technical and quality issues to ensure supply of commercial products. in the Manufacturing Technology and Development (MT&D) organization at Lantheus.

Key Responsibilities/Essential Functions

  • Design and conduct radiochemistry experiments for clinical and commercial drug developments.
  • Critically evaluate data, determine appropriate conclusions and a plan of action in collaboration with internal and external stakeholders to develop GMP production processes.
  • Provide project data and progress status updates to management.
  • Work with cross-functional teams on the development of synthesis, purification, formulation and aseptic filling processes, including process transfer, scale-up, validation and launch activities.
  • Support the preparation and review of written procedures, batch records, experimental protocols and reports, specifications and qualification/validation protocols.
  • Prepare technical reports and documents, including SOPs and investigational reports.
  • Conduct work according to best practices and, where appropriate, regulatory guidance, GMPs, established business processes and protocols, and applicable standard operating procedures
  • Coordinate complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
  • Manage Technical Transfer to CMOs or on-site process and material qualifications. Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
  • Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term and future needs. Lead root-cause analysis investigations as a technical resource.
  • Present data and information as a technical subject matter expert to regulatory agencies.
  • Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
  • Actively demonstrate the Lantheus values.
  • Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.

Typical Minimum Skills and Experience and Education

  • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required.
  • 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of manufacturing process development, process validation, and technical transfer, within a matrixed pharmaceutical, medical device, or biotechnology organization.
  • Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CMO management strongly preferred.

Other Requirements

  • This individual should be a self starter with the ability to work well both independently and in a team environment.
  • Demonstrated technical problem-solving skills with root cause analysis tools.
  • Direct experience with project management skills.
  • Excellent organizational and time management skills.
  • Excellent oral & written communication skills. Demonstrated ability to write and review technical documents and develop and present technical presentation materials.
  • Establishes strong inter-departmental relationships and is viewed as a leader and a valuable technical resource to others.
  • Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies
  • Familiar with Code of Federal Regulations parts 210 and 211 and supporting regulatory inspections
  • Experience in drafting and reviewing of Chemistry, Manufacturing and Controls regulatory filing sections
  • Ability to support travel 20%

Lantheus is committed to equal employment opportunity and non-discrimination 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 is an E-Verify Employer in the United States. Lantheus 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 Talent Acquisition team at talentacquisition@lantheus.com.

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