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Job Description

An excellent opportunity is available for a Senior Scientist specializing in analytical validation design. The primary function of this role is to author and manage validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio within our company. As a Senior Scientist, you will collaborate closely with other functional groups to ensure that methods are validated to current regulatory standards and implemented at their designated testing sites. This vital process will support the successful commercialization of large molecule products and ensure a standardized validation approach across all programs.

Bring energy, knowledge, and innovation to carry out the following:

• Take the lead in creating validation designs and authoring validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio

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

• Work closely will internal and external labs to support the execution of method validations and transfers to ensure proper implementation of methods at the testing sites

• Ensure adherence to timelines by effectively managing review and approval cycles of validation documentation, while maintaining open and clear communication will all key stakeholders

• Communicate effectively across functions and departments to support management and governance teams in escalating risks, managing issues, and developing mitigation plans

What skills you will need: In order to excel in this role, you will more than likely have:

• Bachelor's degree in a chemistry or 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 analytical development or quality control

• Knowledge in the technical aspects of drug substance and drug product analytical methods used for release, stability, process monitoring and characterization of biologics and vaccines, supported by prior hands-on experience

• Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices

• Proven track record of managing processes with the ability to effectively track, support and communicate timely delivery of milestones

• Demonstrated ability to work both independently and within cross-functional teams, whether in-person or remotely, fostering collaboration and achieving team objectives

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

• As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

• As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

• We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

• Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

• Invent solutions to meet unmet healthcare needs, please apply today.

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Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US 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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

*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:R345345