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Job Description

Job Description:

The selected candidate will work in the Analytical Research & Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting medical device and combination product programs at various stages of development. The scope of the role will include realization of the AR&D externalization strategy by leading the build of analytical capabilities and driving a culture of scientific and operational excellence within our team and at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT’s) and external partners to establish timelines for clinical deliveries and will provide oversight of method transfers, as well as release and stability testing for multiple programs. The candidate will also partner with Device Development & Technology (DD&T), Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company’s ways of working and transform them into strategic partners. This role represents an excellent opportunity for a candidate seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs at any given time, and broaden their experience in medical device development.

Primary Responsibilities:

+ Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.

+ Partner with cross functional DCT’s, WG’s (Working Groups), and DD&T to manage externalized projects.

+ Lead analytical development for all medical device and combination product deliverables sited at selected external partners including analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.

+ Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners.

+ Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents.

+ Ensure high quality documentation from external partners consistent with a compliance mindset.

Education Minimum Requirements:

+ A Ph.D. with a minimum of 3 years of relevant experience

+ OR a Master’s degree with a minimum of 6 years of experience

+ OR a Bachelor’s degree with a minimum of 8 years of experience

Preferred Experience & Skills:

+ Outstanding communication, critical thinking, and leadership skills.

+ Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.

+ Experience with working in a fast-paced and dynamic environment.

+ Strong knowledge of medical device CMC landscape including knowledge of ISO and ASTM standards, EU MDR, GMP, ICH and relevant HA guidelines.

+ Experience with medical device development with understanding of Design Controls (21 CFR 820.30)

+ Extensive experience with a wide variety of analytical methods, including but not limited to, device functionality testing and container closure integrity (CCI) testing.

+ Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.

+ Travel (Domestic and/or International) up to 10% of time.

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.

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

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

$139,600.00 - $219,700.00

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 (https://www.benefitsatmerck.com/) .

**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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/21/2025

*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:** R345415