Specialist, Analytical Technical Solutions (ATS)

MSD • De Soto, KS

6d • $87,300 - $137,400 • Hybrid

About The Position

Join our Analytical Technical Solutions (ATS) team as a Specialist providing analytical support assisting in the critical production of veterinary large molecule biotherapeutics. This role involves working in regulated and/or non-regulated environment performing and supporting method development, validation and transfer activities from R&D to QC, from external sites or site-to-site. You will work with a variety of technical equipment independently or under moderate supervision, ensuring highest standards of safety and quality. The position can be based either in Millsboro, Delaware or De Soto, Kansas.

Requirements

• Bachelor’s degree in Life Sciences, Biology, Pharmaceutical Sciences or related fields with 3+ years of experience in biotech or pharma industry.
• Prior hands-on 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.
• Understanding of statistical evaluation of analytical data and familiarity in Empower, Chromeleon, OpenLab ChemStation or equivalent data acquisition 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, excel, PowerPoint 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”.

Nice To Haves

• ELISA, cell based, viral assays (TCID50, plaque assay, neutralization assays) and/or molecular biology experience are a plus.
• Experience working with veterinary products is a plus.

Responsibilities

• Develop, validate and transfer of phase-appropriate analytical methods for characterization and release testing of Large Molecule drug substances and drug products.
• Conduct HPLC based method development for characterization of biologics (may include, charge particle analysis, reduced mass etc.) 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.
• Troubleshoot and maintain lab instruments including but not limited to UPLC, LC-MS, particle counter, nanodrop etc. ensuring they remain in peak operational condition.
• Additional tasks as assigned.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level