Full Job Description
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.
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 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.
Required Education, Qualifications and Skills:
• 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). ELISA, cell based, viral assays (TCID50, plaque assay, neutralization assays) and/or molecular biology experience are a plus.
• Familiarity with regulatory (GMP, USDA, FDA, ICH) guidelines and industry best practices. Experience working with veterinary products is a plus.
• 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".
Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Biopharmaceuticals, Biopharmaceutics, Cell-Based Assays, Dissolution Testing, Driving Continuous Improvement, General Safety, Global Health, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Life Science, Microbiological Analysis, Microbiological Test, Molecular Biology, Multitasking, Self Motivation, Size Exclusion Chromatography (SEC), Teamwork, Technical Writing, Troubleshooting {+ 1 more}
Preferred Skills:
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Current Contingent Workers apply HERE
The salary range for this role is
$87,300.00 - $137,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/23/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.