Scientist I, Manufacturing Sciences

Job Description

About This Role

Biogen Materials Science is a global team of scientists and engineers with a broad range of responsibilities regarding raw materials that requires strong technical skills, as well as an ability to lead cross functional teams. Our team is seeking a motivated scientist to lead the extractables and leachables program, as well as own technical design optimization for single use raw materials. You would be responsible for creation of protocols, review, and approval of data, authoring technical assessment reports and being the key point of contact with testing labs as well as with suppliers. Additionally, we are seeking a scientist with strong chemistry skills that can assess suitability of various plastics and single use technologies for use in gene therapy, antisense oligonucleotide and antibody-based processes.

What You’ll Do
  • Create extractables/leachables protocols, review, and approval of E/L data, authoring extractables/leachables assessment reports
  • Represent Materials Science during agency inspections as a subject matter expert for answering questions on raw materials
  • Lead/supervise cross functional teams with dotted line reports for single use raw materials projects.
  • Review and assess raw material vendor change notifications for technical approval.
  • Author of raw materials sections for key regulatory filings.

Who You Are

The ideal candidate will have technical expertise in chemistry with a focus in polymeric chemistry as well as working knowledge of analytical techniques such as GC-MS, LC-MS and ICP-MS. Additionally, you would enjoy working with teams of people from many cross functional areas.

Qualifications

Required Qualifications:
  • Master’s Degree
  • 4+ years of experience in GMP environment (Analytical Chemistry or related discipline)

Preferred Qualifications:
  • PhD.
  • 0+ years’ experience in GMP environment.
  • Experience in the field of extractables/leachables.
  • Technical expertise in polymerics manufacturing, chemistry, and suitability of use for single use systems and container closure.
  • Specialized technical expertise in chemistry with a focus in polymeric chemistry with working knowledge of analytical techniques such as GC-MS, LC-MS and ICP-MS.
  • Experience applies scientific and analytical skills to assess suitability of various plastics and single use technologies with multiple manufacturing modality needs.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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