Associate Principal Scientist, Analytical External Capabilities/Devices
Associate Principal Scientist, Analytical External Capabilities/Devices
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 139600 - 219700
1 Vacancy
Job Description
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 (DCTs) 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 companys 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&Ds externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.
Partner with cross functional DCTs WGs (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 companys 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 Masters degree with a minimum of 6 years of experience
OR a Bachelors 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 fastpaced 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
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 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:
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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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:
$139600.00 $219700.00Available 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
