Job Information
Merck Analytical Methods Specialist in De Soto, Kansas
Job Description
Maintains compliance according to USDA guidelines and requirements for reference standards and in vitro potency assays
Assists in the routine maintenance and management of the reference standard program for two U.S. veterinary biologics sites
Participates, collaborates in, and/or leads cross-functional project teams with colleagues in Research & Development, Bioprocess Technology Solutions, Production, Quality Control, and Regulatory Affairs to qualify new reference standards
Conducts in vitro stability testing for reference standards of pre- and post-licensure products
Supports and/or leads cross-functional teams in simple and complex investigations for in-line Quality Control assays
Supports and/or leads method improvement lab activities across multiple test platforms including live virus and bacterial titrations, hemagglutination assays, and ELISAs
Leads and/or provides technical support in the development and validation of in vitro analytical tests, including experimental design, in collaboration with R&D for new product commercialization as assigned
Prepares and/or audits in vitro test data for statistical analysis
Leads or assists in the preparation of protocols or reports for submission to regulatory authorities
Participates in critical reagent validation studies, including routine monitoring of critical reagent inventories
Supports local, regional, and global program initiatives as assigned
Maintains periodic laboratory cleaning and equipment calibration as assigned
Adheres to good documentation practices, including data integrity standards
Education Minimum Requirement:
- Bachelor’s Degree in a Relevant Biological Area (Biology, Genetics, Immunology, Microbiology, Virology)
Required Experience and Skills:**
At least 5 years bench level laboratory experience in the Animal Health industry, preferrably in an analytical support role or R&D
Subject matter expertise in at least one biological area and at least one analytical platform; experience in other biological areas and analytical platforms
Proficient in technical writing and use of Microsoft programs (Excel, PowerPoint, Word)
Preparation of protocols, reports, and/or data packages for regulatory authorities
Proficient communication skills, which may include past involvement in cross-functional teams and the ability to summarize data and results to internal and external stakeholders
Preferred Experience and Skills:
At least 1 year Quality Control experience
Project management experience
Data evaluation including basic statistics
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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”.
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/27/2024
*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.
Job Posting End Date: 09/27/2024
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.
Requisition ID: R311616