Senior Scientist, Bioanalytical Sciences & CRO Management
Cambridge, MA, USA | Alnylam Pharmaceuticals
Industry:Pharmaceutical / Biotech
Job Description:62 people have viewed this job
The Bioanalytical Sciences group at Alnylam is seeking a highly motivated Senior Scientist to join our team to help advance novel RNAi therapeutic programs from discovery to the clinic. This position in Bioanalytical Sciences, as part of DMPK/Early Development (eDEV) organization, has roles and responsibilities to oversee Contract Rresearch Organization bioanalysis work for assigned programs to support PD/safety biomarkers, PK/TK, metabolism, drug distribution, and immunogenicity.
Summary of Key Responsibilities
Report to Bioanalytical Sciences’ Outsourcing manager and responsible for assigned programs for CRO bioanalysis management.
Manage CRO assigned bioanalysis outsourcing activities for PD/safety biomarkers, PK/TK, and immunogenicity in both non-clinical and clinical studies under regulated laboratory environment (GLP/GCLP) with an emphasis on biomarkers.
Provide CRO oversight for agreed upon deliverables, submit quality bioanalysis data and reports according to timelines.
Collaborate with Alnylam biomarker assay development managers to transfer methods to CROs and manage CRO assay development, validation, and sample analysis for assigned programs.
Participate in routine CRO meetings, review study plans, data, and reports.
Participate in writing regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA) for assigned programs.
Serve as Bioanalysis representative to interact with Alnylam non-clinical and clinical teams and participate in program related meetings.
Ph.D. in biochemistry, pharmaceutical sciences, chemistry, or equivalent expertise areas with 3+ years of industry experience (in biotech, pharmaceutical, and/or CROs) in bioanalysis in biotech/pharmaceutical companies with strong understanding of biomarker assays supporting drug development.
Previously managed CRO bioanalysis work and/or direct experience as CRO scientist/PI with sponsor interactions are required.
Experienced in drug approvals with biologic and/or small molecule drugs.Knowledge with nucleic acid drug (such as siRNA, ASO, mRNA, or gene therapy) is highly desirable.
Previously worked in a GLP, GCLP, and/or CLIA compliant bioanalytical lab environment is required.
Managed timelines and deliverables (data and bioanalysis reports) for specific programs.
Have in-depth scientific knowledge and hands on technical expertise on ligand binding assays (e.g., ELISA, MSD, Luminex, Quanterix), immunogenicity assays, and qPCR.
Organized with ability to multi-task and work with cross-functional teams as a team player.Possesses excellent verbal and written communication skills, excellent presentation skills, and is detail oriented.
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