Scientist, Drug/Device Combination Products (Onsite)

Merck; Rahway (NJ); Hybrid; USD 85,000 - 135,000; Full time

Job summary

An innovative company is seeking a dedicated Scientist to join its Device Product & Process Development Team. This role focuses on container closure integrity technology, where you'll develop and validate methods for various combination products, including biologics and vaccines. You'll be a key player in ensuring the safety and effectiveness of drug delivery systems. If you have a passion for scientific advancement and enjoy collaborating with cross-functional teams, this opportunity offers the chance to make a significant impact in the pharmaceutical industry while working in a hybrid environment that promotes work-life balance.

Benefits

Health care benefits

Retirement benefits

Paid holidays

Vacation days

Sick leave

Bonus eligibility

Long-term incentive programs

Qualifications

• 3+ years of relevant work experience in pharmaceutical or biotechnology industries.
• Experience with container closure integrity methods and analytical execution.

Responsibilities

• Develop and validate methods for container closure integrity testing.
• Provide technical leadership and mentorship to junior scientists.

Skills

Analytical Chemistry

Biomedical Engineering

Data Analysis

Project Management

Communication

Education

B.S./M.S in Mechanical Engineering

B.S./M.S in Biomedical Engineering

B.S./M.S in Pharmaceutical Sciences

Job description

Job Description

Scientist - Container Closure Integrity Development

Our company’s Device Product & Process Development (DPPD) Team 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 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, testing, and method validation 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

• Provide technical leadership and mentorship to junior scientists and team members.

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

• Author technical reports and testing protocols

• Review technical data to ensure compliance with cGMP standards

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

Minimum Education Requirement

• B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline witha minimum of 3+ yearsof relevant work experience in the pharmaceutical, biotechnology, or medical device industries

Experience | Knowledge | Skills:

• Relevant analytical execution, development, validation, and/or qualitycontrol (QC) forcontainer 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:

• 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

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

  • Ability to effectively identify and communicate risks.

  • Experience with other analytical methodology

#eligibleforERP

#AR&D

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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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:

$85,600.00 - $134,800.00

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:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Analytical Chemistry, Analytical Chemistry, Bioanalysis, Biomedical Engineering, Biopharmaceutical Industry, Biotechnology, Business, Cell-Based Assays, Chemical Biology, Communication, Data Analysis, Engineering Technology, Mechanical Engineering, Mechatronics, Medical Device Technologies, Medicinal Chemistry, Motivation Management, Multi-Management, Organic Chemistry, Pharmacotherapeutics, Product Commercialization, Production Process Development, Project Management, Science, Self Motivation {+ 4 more}

Preferred Skills:

Job Posting End Date:

05/23/2025

*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.

Requisition ID:R348518