Job Abstract

Job Description

CoE Microbiology within Analytical Research and Development (ARD) at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation & qualification of release and stability methods, to join our Center of Excellence Microbiology team. The primary responsibility is to manage and oversee validation and transfer of microbiological test methods for all modalities from our Research & Development Division to our Manufacturing Division global network.  You will work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately transferred from our Research & Development Division space our Manufacturing Division testing sites.   

Job Responsibilities:

• Develop microbiological method validation protocols/reports, method transfer protocols/reports

• Support follow up studies post transfer activities (RY or WP as needed).

• Apply project management tools to support validation and transfer activities for pipeline commercialization and inline supply projects

• Manage and serve as contact for internal/external labs in analytical method validation and transfer activities

• Maintain timelines; manage review and approval of validation and transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transfer

• Communicate effectively across functions and departments to assist management and governance teams in risk escalation, issue management and mitigation plan development

• Support subject matter experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections where needed.

Required Qualifications:

• Education & experience:  Bachelor's degree in, (Micro-)Biology, - related field with a minimum of 5 years of relevant experience or Master's degree with a minimum of 3 years of relevant experience in microbiological/analytical development or quality control

• Knowledge in the technical aspects and prior hands-on experience of microbiological methods used for release, stability, and process monitoring of protein and conjugate vaccines, adjuvants, and biologics such as monoclonal antibodies, small molecules.

• Project management experience tracking, supporting and communicating timely delivery of milestones

• Ability to work independently and within cross-functional teams, strong team player.

• Strong knowledge and experience in application of current Good Manufacturing Practices to analytical activities within a quality management system

Preferred Qualifications:

• Experience using project management, validation and EDMS solutions (e.g. scheduling tools, PowerBI, Kneat,QualityDocs, VeevaVault)

• Knowledge in current major market regulatory frameworks and prior experience in preparing regulatory submissions in common technical document format

• cGMP experience

• Rapid Microbiological methods knowledge.

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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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. 

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