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Methods Specialist

Merck • Elkhorn, NE 68022 • Posted 8 days ago

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In-person • Full-time • Senior Level

Job Highlights

Using AI ⚡ to summarize the original job post

The Methods Specialist at Merck supports and/or leads method improvement lab activities across multiple test platforms including live virus and bacterial titrations, hemagglutination assays, and enzyme-linked immunosorbent assays (ELISAs). This role involves leading and providing technical support in the development and validation of in vitro analytical tests, preparing and auditing data for statistical analysis, and leading or assisting in the preparation of protocols or reports for regulatory authorities. The position requires collaboration with various teams and adherence to good documentation practices, including data integrity standards.

Responsibilities

  • Supports and/or leads method improvement lab activities across multiple test platforms including live virus and bacterial titrations, hemagglutination assays, and enzyme-linked immunosorbent assays (ELISAs)
  • Leads and/or provides technical support in the development and validation of in vitro analytical tests, including experimental design, in collaboration with Research & Development (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
  • Supports and/or leads cross-functional teams in simple and complex investigations for in-line Quality Control assays
  • Routine collaboration with Analytical Technology Solutions, Bioprocess Technology Solutions, Research & Development, Regulatory Affairs, Production, and Quality Control colleagues
  • Supports local, regional, and global program initiatives as assigned
  • Supports reference program activities as needed
  • Maintains periodic laboratory cleaning and equipment calibration as assigned
  • Adheres to good documentation practices, including data integrity standards

Qualifications

Required

  • Bachelor's Degree in a Relevant Biological Area (Biology, Genetics, Immunology, Microbiology, Virology)
  • At least 5 years bench level laboratory experience in the Animal Health industry, preferably 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

Preferred

  • At least 1 year Quality Control experience
  • Project management experience
  • Data evaluation including basic statistics

About Merck

Merck is a leading biopharmaceutical company based in the United States, specializing in medicines and vaccines for various diseases. It operates globally, offering prescription medicines, vaccines, biologic therapies, animal health products, and over-the-counter consumer healthcare products in over 60 countries. Merck is known for its research, development, and innovation in addressing healthcare needs, including its involvement in developing solutions during the COVID-19 pandemic.

Full Job Description

**Job Description**

**​Responsibilities:**

+ Supports and/or leads method improvement lab activities across multiple test platforms including live virus and bacterial titrations, hemagglutination assays, and enzyme-linked immunosorbent assays (ELISAs)

+ Leads and/or provides technical support in the development and validation of in vitro analytical tests, including experimental design, in collaboration with Research & Development (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

+ Supports and/or leads cross-functional teams in simple and complex investigations for in-line Quality Control assays

+ Routine collaboration with Analytical Technology Solutions, Bioprocess Technology Solutions, Research & Development, Regulatory Affairs, Production, and Quality Control colleagues

+ Supports local, regional, and global program initiatives as assigned

+ Supports reference program activities as needed

+ Maintains periodic laboratory cleaning and equipment calibration as assigned

+ Adheres to good documentation practices, including data integrity standards

**Position Qualifications** **:**

**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, preferably 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.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**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 click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**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, 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".

**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):**

: Potential exposure to BSL 2/3 microorganisms and standard materials used to prepare product

**Job Posting End Date:**

09/19/2024

***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:** 09/19/2024

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:** R312262