Specialist, Analytical Technical Solutions; ATS

Position: Specialist, Analytical Technical Solutions (ATS)
** Job Description
** Join our Millsboro 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 analytical methods and technical equipment independently or under moderate supervision, ensuring highest standards of safety and quality.
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* Key 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.
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* Education Requirements:

*** Bachelor’s degree in Life Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
** Required

Experience and Skills:

*** 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”.Our Manufacturing & Supply Division is committed to be the most trusted supplier of Animal Health biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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* Required Skills:

** Adaptability, Adaptability, Analytical Chemistry, Aseptic Manufacturing, Bioanalysis, Biochemical Analysis, Biochemical Tests, Biochemistry, Capillary Electrophoresis (CE), cGMP Compliance, Column Chromatography, Data Analysis, Decision Making, Documentation Review, EHS Compliance, FDA Regulations, Immunochemistry, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Liquid Chromatography-Mass Spectrometry (LC-MS), Multitasking, Quality Inspections, Quality Operations, Regulatory Compliance {+ 2 more}
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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