Senior Scientist, Analytical Sciences

Alnylam PharmaceuticalsCambridge, MA
1dOnsite

About The Position

Analytical Development at Alnylam is seeking a highly motivated Senior Scientist with expertise in Bioassay including cell-based assays using different cell types and detection formats, qPCR, ELISA . This role involves performing non-GMP in-house Bioassay method development, testing while supporting and overseeing method development , GMP testing at external laboratories. In this role, you will be an individual contributor. This is a full time, onsite position based in Cambridge, MA.

Requirements

  • Ph.D. in a scientific discipline with 5 years of experience in biotechnology or pharmaceutical laboratory is required.
  • Strong expertise including hands-on experience with cell-based assays, ELISA, and qPCR.
  • Robust understanding of regulatory guidance and industry standards relevant to bioassay related CMC activities, particularly in the development and validation of bioassays.
  • Strong scientific, analytical problem solving and communication skills are required.
  • Demonstrate adaptability and a willingness to support changing priorities and evolving departmental needs
  • Highly organized, detail-oriented and computer proficiency to handle related scientific tasks.
  • Ability to work independently in a fast pace work environment and prioritize several projects with minimal supervision.
  • Flexibility to travel to CTLs\CMOs on an as needed basis.

Nice To Haves

  • Experience with microbiological tests preferred.

Responsibilities

  • Perform and oversee cell based assays including ELISA and qPCR as well as microbiology tests.
  • Lead feasibilities, development and transfers for cell based assays internally and externally, building and maintaining key relationships at CTLs.
  • Apply deep knowledge of regulatory guidelines (ICH, USP chapters) to ensure compliance in bioassay development and validation as well as data verification.
  • Provide bioassay technical leadership within assigned programs and offer guidance across other programs as needed.
  • Draft, review and/or approve protocol, reports, certificates of testing.
  • Record results of analysis in electronic notebook and/or in appropriate documentation method.
  • Participate in cross-functional training and facilitate continuous improvement.
  • Provide training and mentorship to colleagues and junior scientists within this area of expertise.

Benefits

  • We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
  • Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
  • We also offer generous family resources and leave.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

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