myGwork - LGBTQ+ Business Community · 1 week ago

Senior Scientist - Data Review

Boston, MA

Full-time

Onsite

Senior Level

4+ years exp

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Responsibilities

Perform technical review of analytical data for both CQC Lab and reference standard

Handle and fulfil reference standard shipment requests including aliquoting material for shipment

Handle in-use and back-up reference standard inventory

Generate, approve, and distribute COAs

Use data analytics and tools to generate metrics and drive continuous improvement

May lead OOT/OOS investigations, deviations, and identify corrective actions to prevent reoccurrence

Authors, reviews and approves data, SOPs, analytical methods, protocols and reports

May perform laboratory activities and testing as needed

Maintain accurate testing records and adhere to cGMP/GDP expectations

May participate in planning, implementing, or reviewing method validations and/or method transfers

Perform other laboratory duties as assigned

Participates in compliance related teams working towards the goal of continuous improvement

Qualification

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Solid understanding of cGMPAnalytical Techniques HPLCAnalytical Techniques GCAnalytical Techniques KFAnalytical Techniques ROIAnalytical Techniques XRDAnalytical Techniques TGAMethod Validation/TransferDrug Substance TestingDrug Product TestingOral Solid Dosage FormsAttention to DetailEffective Interpersonal Skills

Required

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')

OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')

OR PhD

Solid understanding of cGMP in a pharmaceutical setting

Solid understanding in analytical techniques in a QC/commercial setting (e.g. HPLC, GC, KF, ROI, XRD, TGA, etc.), including method validation/transfer

Experience with both drug substance and drug product (oral solid dosage forms) testing

Attention to detail

Effective interpersonal skills, both verbal and written