This job has closed.

Menarini Silicon Biosystems · 1 month ago

Quality Control Senior Scientist

Huntingdon Valley, PA

Full-time

Hybrid

Mid, Senior Level

1+ years exp

Menarini Silicon Biosystems, Inc. develops technologies and products that help to understand the biological complexity of disease through the study of single cells. The Senior Scientist will engage in all QC lab operations, performing testing of raw and in-process materials and finished products, while ensuring compliance with regulations and continuous improvement of processes.

BiotechnologyClinical TrialsHealth Care

Hiring Manager

Stacey Verdino

Responsibilities

Perform physical and chemical analysis of raw materials, in-process, and finished materials, including stability studies, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs)

Comply with GMP procedures and SOPs to avoid out-of-specification situations. Assure compliance with state and federal regulations

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using bench, chromatographic techniques and analyzers. Creates and maintains laboratory record documentation, documents exact steps followed during analysis execution, calculates and reports results in a timely manner

Experience and comfort with laboratory processes and protocol, as well as the use of: Spectrophotometers, Flow cytometry and cell counters (counting, MFI), HPLC, FISH, TOC analyzers, Plate readers, Osmometers, pH meters, Analytical balances, Titrators

Perform daily, monthly calibrations/ verifications on QC instruments

Create/revise QC documents in document management system

Write OOS, non-conformances, change controls related to QC, in TrackWise

Other duties as assigned

Qualification

Analytical chemistry techniquesGMP complianceChromatographic techniquesSpectrophotometryFlow cytometryHPLCProblem-solvingDocumentation skillsTeam collaboration

Required

Bachelors' Degree (BA/BS) in Chemistry or related science discipline is required

1-5 years of testing of chemicals/pharmaceuticals products

Working in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, chromatographic techniques and measuring physical parameters such as particle size

Use of biomarkers, antibodies and Ab-dye conjugates to tag and characterize cells

Must understand and apply GMP requirements applicable to the quality control laboratory

Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to supervisor in a timely manner

Comply with GMP procedures and SOPs to avoid out-of-specification situations. Assure compliance with state and federal regulations

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using bench, chromatographic techniques and analyzers

Creates and maintains laboratory record documentation, documents exact steps followed during analysis execution, calculates and reports results in a timely manner

Perform daily, monthly calibrations/ verifications on QC instruments

Create/revise QC documents in document management system

Write OOS, non-conformances, change controls related to QC, in TrackWise