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Senior Scientist, Outsourcing Bioanalysis

Alnylam Pharmaceuticals Inc.


Location:
Cambridge, Massachusetts 02142
Date:
01/18/2018
2018-01-182018-03-19
Job Type:
Employee
Job Status:
Full Time
Alnylam Pharmaceuticals Inc.
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Job Details

Senior Scientist Outsourcing Bioanalysis 

Overview:

Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics.  The Bioanalytical Sciences department at Alnylam is seeking an experienced scientist to join our fast-paced team to advance our RNAi therapeutic programs from discovery to the clinic.  The successful candidate will join the bioanalytical outsourcing team and have strong scientific knowledge in chromatography (mass spectrometry and HPLC) and ligand binding assays (LBA), experience with GLP and GCLP regulations in pharmaceutical/biotech/CRO environment.  The candidate will interact with Alnylam teams and with our CROs for method transfers, method validations, sample analysis management, and report review for nonclinical and clinical studies.      

Summary of Key Responsibilities:                                                                                                     

  • Manage bioanalytical sample analysis as part of Alnylam’s Bioanalytical outsourcing group for nonclinical and clinical projects by working closely with Bioanalytical, Clinical, Clinical Pharmacology, Toxicology, and DMPK teams to ensure project objectives and deliverables. 
  • Ensure the validation of assays meet regulatory expectations and scientific soundness for the bioanalysis of pharmacokinetic, immunogenicity and biomarker assays for nonclinical and clinical studies.
  • Contribute and review in a timely manner documents and reports (bioanalysis validation protocols, sample analysis plans, and reports) generated by CROs.  
  • Collaborate with development teams as a departmental liaison to communicate project time lines and data needs to CROs and manage adherence to time lines.  Timeline management is key for a successful candidate.
  • Work with Clinical Operations to support Bioanalytical aspects of a clinical study:  e.g. sample analysis management, lab manuals, data requirements for date reviews and regulatory documents.

Qualifications:

Requirements include a PhD in chemistry, biochemistry, or related fields with 3+ years of bioanalytical and/or outsourcing experience.  Exceptional non-PhD candidates with 10-12 years of experience will be considered.  Experience managing CROs or interacting with sponsors is preferred.  Hands on experience in a GLP/GCLP lab preforming mass spectrometry or HPLC analysis, including assay failure troubleshooting and method development, is required.  Proficiency in data and report QC and editing are also required, along with ease in using Excel, PowerPoint, and Word.  Knowledge in LBAs is and qPCR is preferred.  Excellent communication skills (both written and oral) and interpersonal skills are expected.  Excellent organization skills and attention to details are essential.  Experience with inspection/audit readiness for late-stage programs is also preferred.

Alnylam Pharmaceuticals is an AA/EEO employer committed to an exciting, diverse, and enriching work environment.

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