Senior Scientist, Drug/Device Combination Products

Job Description

Senior Scientist - Container Closure Integrity Development

 

Join our company’s Device Product & Process Development (DPPD) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

The Senior Scientist will lead DPPD within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, method validation, and testing for various product images (vials, syringes, cartridges, and injectors) and secondary packaging.

The candidate will develop methods for our company’s device and combination product pipeline, inclusive of small molecule, biologics, and vaccine products.

 

Key Responsibilities

• Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods.

• Ability to build, mentor, and train laboratory staff and users, ensuring proper execution of test methods, adherence to procedures, and consistent data quality.

• Develop, validate, and execute feasibility CCI studies for complex combination devices & delivery systems.

• Author technical reports and testing protocols.

• Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs.

• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.

• Self-motivated with ability to work independently.

• Skilled in laboratory good documentation practices and electronic documentation systems.

• Working knowledge of analytical test method technology transfer process.

• Willing to travel.

  

Minimum Education Requirement

• B.S./M.S in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 4-8 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries.

• PHD Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences.

Required Experience | Knowledge | Skills:

• Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products.

• Ability to learn new techniques, troubleshooting assays, author and review technical documents.

• Excellent organizational skills to manage multiple projects.

 

Preferred Experience | Knowledge | Skills:

• cGMP experience.

• Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis.

• Fluency with industry-related guidance USP <1207> and ISO-13485.

• Good technical, communication (oral and written), interpersonal, and teamwork skills. 

• Ability to effectively identify and communicate risks.

• Experience with other analytical methodologies.

Required Skills:

Analytical Chemistry, Analytical Chemistry, Analytical Method Development, Biomedical Engineering, Biotechnology, Chemical Engineering, Chemical Technology, Creativity, External Partners, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Method Validation, Motivation Management, Multi-Management, Negotiation, Product Development, Project Management, Prototyping, Self Motivation, Statistical Analysis, Teamwork, Technical Writing {+ 1 more}

Preferred Skills:

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 another’s thinking and approach problems collectively.

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The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/29/2026

*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.