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Merck · 4 hours ago

Specialist, Analytical Technical Solutions (ATS)

Millsboro, DE

Full-time

Hybrid

Mid Level

$87K/yr - $137K/yr

Merck is seeking a Specialist to join their Analytical Technical Solutions team in Millsboro, providing analytical support for the production of veterinary large molecule biotherapeutics. The role involves method development, validation, and transfer activities, ensuring compliance with safety and quality standards.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Develop, validate and transfer of phase-appropriate analytical methods for characterization and release testing of Large Molecule drug substances and drug products

Conduct LC and LC-MS based method development for characterization of biologics (may include, charge particle analysis, reduced mass, intact mass, peptide mapping and glycan mapping) to provide better understanding of biologics attributes

Interface with collaborators, CROs and CDMOs to facilitate method development, validation and transfer activities

Author, review and approve test procedures, protocols, and reports

May serve as a SME and aid in investigation of deviations, OOS and OOT analytical results

Plan, execute, document and data analysis and present results to multidisciplinary team

Troubleshoot and maintain lab instruments including but not limited to UPLC, LC-MS, osmometer, nanodrop etc. ensuring they remain in peak operational condition

Qualification

Analytical ChemistryLiquid ChromatographyLC-MSBiochemical AnalysisRegulatory ComplianceData AnalysisCGMP ComplianceMultitaskingInterpersonal RelationshipsDocumentation ReviewAttention to Detail

Required

Bachelor's degree in Life Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field

Prior biotech experience in analytical method development for large molecules or proteins/monoclonal antibodies preferred

Knowledge of method development and characterization of protein therapeutics using various analytical techniques, including liquid chromatography (HPLC/UPLC/FPLC, size exclusion chromatography, LC-MS), SDS-PAGE, Western blot, UV-Vis spectrophotometry, particle size by DLS or equivalent and capillary electrophoresis (CE-SDS)

Familiarity with regulatory (GMP, USDA, FDA, ICH) guidelines and industry best practices is a plus

Understanding of statistical evaluation of analytical data and familiarity in data acquisition using Chromatography Data Systems (CDS) and processing software

Ability to multitask and work in a fast-paced environment

Good attention to detail and ability to thoroughly document experiments, data, technical reports and findings electronically in an accessible manner with good documentation practices

Familiarity with standard office software (MS Office, Teams, SharePoint etc.)

The candidate should be self-motivated, accountable and possess excellent organization skills

Ability to follow Global Health, Safety and Environment guidelines while performing routine tasks upholding our company's commitment to 'Safety First, Quality Always'

Adaptability

Analytical Chemistry

Aseptic Manufacturing

Bioanalysis

Biochemical Analysis

Biochemical Tests

Biochemistry

Capillary Electrophoresis (CE)

cGMP Compliance

Column Chromatography

Data Analysis

Decision Making