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Senior Methods Specialist - Analytical Technology Support

Senior Methods Specialist - Analytical Technology Support

MSD MalaysiaDe Soto, KS, US
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Job Description Join Us in Shaping the Future of Animal Health Our Animal Health Global Manufacturing teams are focused on reducing cost of goods to enable delivery of cost-effective, life-changing vaccines for our customers and patients. At our Midwest site(s) you will be part of a world-class team driving hands-on analytical method development and robust site-to-site method transfers that support production and testing of veterinary products worldwide. Key Responsibilities

  • Lead and execute hands-on method development and improvement activities at the bench across multiple bioassay platforms (e.g., ELISA, virus titration, HA / HI). Design experiments, run assays, analyze results, and implement technical fixes to improve accuracy, precision, sensitivity, and robustness.
  • Plan and manage site-to-site analytical method transfers : develop transfer plans, perform parallel testing, document equivalency, troubleshoot discrepancies, and close transfer gaps to achieve successful adoption.
  • Perform complex data analysis and trending to identify non-robust methods and root causes; partner with data analytics and statistics to guide experimental design and acceptance criteria.
  • Write and maintain technical documents to support transfers and development efforts, including protocols, SOPs, validation reports, and technical summaries suitable for QC and regulatory review.
  • Lead cross-functional project teams and coordinate with stakeholders across Quality Control, Operations, Bioprocess Technology Solutions, Regulatory Affairs, and Analytical Technology Solutions across five U.S. sites.
  • Use internal systems to manage project plans, track milestones and risks, and report progress to site and regional leadership.
  • Present technical findings, status updates, and risk-mitigation plans to team, site, and regional stakeholders.
  • Mentor and train QC staff on new or transferred methods to ensure reproducible implementation and ongoing compliance. Qualifications : Education Minimum Requirement : Bachelor's degree in Biology, Immunology, Microbiology, Virology, or a related biological science. Required Experience and Skills :
  • 3–5 years' hands-on bench experience developing, validating, and transferring analytical methods within a QC or analytical lab (in vitro bioassays emphasized).
  • Demonstrated project management experience leading analytical method transfers and improvement projects across multiple sites.
  • Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA / HI) with practical experience executing assays and troubleshooting instrumentation and assay performance.
  • Proven ability to perform bioassay data analysis, trending, and interpretation; able to translate data into concrete technical actions and acceptance criteria.
  • Strong technical writing skills for protocols, validation reports, and technical documentation.
  • Proven cross-functional collaboration skills, including experience working with QC, Manufacturing, Regulatory, and R&D teams and coordinating activities across multiple locations.
  • Detail-oriented, proactive, and able to balance bench-level work with project leadership responsibilities. Preferred Skills and Experience :
  • Experience with method development focused on USDA requirements and animal health processes.
  • Familiarity with automated imagers, liquid handlers, and other analytical technologies used to scale and transfer methods.
  • Experience designing experiments for bioassays and working with statistical acceptance criteria.
  • Experience presenting technical data to cross-functional stakeholders and leadership. What We're Looking For We seek individuals who :
  • Demonstrate execution excellence through effective problem-solving and critical thinking .
  • Embrace an entrepreneurial mindset , taking initiative and ownership of their work.
  • Adapt with agility and resilience in a dynamic, fast-paced environment.
  • Uphold a safety-first mindset , ensuring the well-being of themselves and their colleagues. Embrace ambiguity and adapt with resilience . Be part of a transformative organization that will shape the future of animal health
  • Work with a dynamic and experienced team
  • Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products
  • Help us meet growing global demand for our portfolio of animal health solutions Required Skills : Analytical Assays, Analytical Method Development, Assay Transfer, Assay Validation, BioAssay, Data Analysis, Design of Experiments (DOE), Laboratory Analytical Techniques, Method Development, Statistical Design of Experiments (DOE), Technical Writing Preferred Skills : Analytical Laboratory, Animal Health Care, USDA RegulationsCurrent Employees applyCurrent 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.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit : We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The salary range for this role is$94,300.00 - $148,500.00This 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 .You

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Technology Support Specialist • De Soto, KS, US

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