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Job Description

The Molecular & Viral Safety group within Cell Based Sciences, Analytical R&D, is seeking applicants for a Senior Scientist position located at our West Point, PA, research facility. The successful candidates will contribute to delivering analytical solutions that enable and accelerate process and product development to ensure safety and quality of our products. As a member of the Molecular Biology team, key roles and responsibilities will include the design and development of new molecular biology assays to be used in support of process development and GMP manufacturing.

The successful candidates will be able to collaborate in a dynamic, integrated, and multidisciplinary team environment working across our vaccine product pipeline. An expansive range of analytical tools (e.g. microbiology, molecular biology, Sanger and next generation sequencing, etc.) will be leveraged and new technologies developed to ensure the safety and efficacy of our leading products.

Responsibilities include:

• Design, develop, and complete phase-appropriate validation for molecular based assays to support release, characterization testing and process development across our vaccine product pipeline.

• Build and maintain deep technical expertise in the area of analytical assay development and testing, including implementation of analytical Quality-by-Design concepts and tools.

• Author technical documents including method procedures, testing protocols, and assay development reports according to current regulatory requirements and business practices.

• Demonstrate effective multitasking, prioritization, and problem-solving skills in the operational oversight for release and characterization testing of vaccine products.

• Contribute to sections of regulatory filing documents.

• Contribute to solving complex problems and technical advances in the field.

• Effectively collaborate in a fast-paced, integrated, multidisciplinary team environment.

Education Minimum Requirement:

• A Ph.D.; or a master’s degree with a minimum of 5 years’ experience; or bachelor’s degree with a minimum of 8 years’ experience in virology, microbiology, molecular biology, biological sciences, or related discipline in the biopharmaceutical industry.

Required Experience and Skills:

• Strong background and direct experience with a variety of virology, molecular biology, and microbiology techniques to understand and solve diverse scientific questions.

• ​Demonstrated scientific ability through publications in peer reviewed journals and presentations in scientific conferences.

• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.

• Ability to deliver complex objectives under strict timelines in a rapidly changing environment.

• Ability to work in a diverse, cross-functional team environment.

Preferred Experience and Skills:

• Working knowledge of regulatory and industry guidelines in the area of biosafety testing, including compendial requirements, CFR and ICH requirements, and WHO/EMA/FDA regulations.

• Familiarity with electronic laboratory notebook applications and good documentation practices.

• Prior work in a biopharmaceutical industry and knowledge of cGMP practices

• Prior background in biologics and/or vaccine GMP manufacturing or analytics.

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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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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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

07/2/2024

*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: 07/02/2024

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: R298959