Associate Principal Scientist, Device Analytical Lead in Analytical Research & Development (Hybrid)

Job Description

An excellent opportunity is available for an Analytical Research and Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various stages of development. In this pivotal position, the successful candidate will spearhead analytical device activities across multiple MDCP programs, serving as a key member of the Combination Product Analytical sub-team within the Combination Product Working Group. The Device Analytical Lead will partner closely with cross-functional teams, including device development and technology, quality assurance, and analytical teams involved in GMP activities, validation and Quality Control testing. This role will be instrumental in establishing timelines for clinical deliverables and ensuring commercial laboratory readiness for product launches.

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

• Take the lead in overseeing device GMP analytical activities for multiple MDCP programs

• Execute AR&Ds device strategy and optimization of the operating model to deliver results aligned with enterprise goals

• Develop an incoming and release testing strategy, lead siting discussions for clinical and commercial testing, and develop specifications

• Ensure adherence to timelines by effectively managing all analytical activities to support on time release of clinical supplies

• Work with the validation team on method validation and transfer activities at clinical GMP labs and commercial QC labs

• Partner with cross-functional device, analytical, regulatory and quality functions within our divisions to manage End-to-End MDCP testing activities including internal and external device testing activities

• Support regulatory filings through documentation authoring and reviews (i.e. INDs, BLAs, etc.)

Required experience & skills:

• A Ph.D. with a minimum of 3 years of relevant work experience or a Masters degree with a minimum of 6 years of relevant work experience or a Bachelors degree with a minimum of 8 years of relevant work experience

• Proven track record of successful project management, encompassing resource management, risk assessment and mitigation strategies, as well as the ability to effectively track, support and communicate the timely delivery of project milestones

Preferred experience & skills:

• In-depth knowledge of medical device CMC landscape including knowledge of ISO 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 device analytical methods, including but not limited to, device functionality testing and container closure integrity (CCI) testing

• Outstanding communication, critical thinking, and leadership skills

• Proficient in navigating fast-paced and dynamic work environments

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

#eligibleforERP

#AR&D

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.

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:

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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 anothers 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 candidates 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 .

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Combination Products, Communication, Critical Thinking, Cross-Functional Teamwork, Enterprise Risk Management (ERM), Environment Management, External Collaboration, Fast-Paced Environments, GMP Compliance, High Resolution Mass Spectrometry (HRMS), Innovation, ISO Standard, Liquid Chromatography-Mass Spectrometry (LC-MS), Machine Learning, Mass Spectrometry Analysis, Medical Device Management, Medical Devices, Medical Devices Design {+ 19 more}

Preferred Skills:

Job Posting End Date:

06/4/2025

*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.