Scientist, Drug/Device Combo Products

MSD•Rahway, NJ

7d•Hybrid

About The Position

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.

Requirements

B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with a minimum of 1 year of relevant work experience in the pharmaceutical, biotechnology, or medical device industries
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
Accountability
Analytical Chemistry
Biocompatibility
Biomedical Engineering
Biomedical Sciences
Biopharmaceutical Industry
Biotechnology
Clinical Supply Chain Management
Combination Products
Cross-Functional Planning
Data Analysis
Human Factor Engineering
Innovation
Interpersonal Relationships
Machine Learning (ML)
Manufacturing Processes
Materials Science
Mechanical Engineering
Mechanical Testing
Medical Device Technologies
Medical Product Development
Pharmacology
Production Process Development
Prototyping

Nice To Haves

Hands-on experience in container closure integrity technology ( 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 understanding of USP <1207>
Good technical, communication (oral and written), interpersonal, and teamwork skills.
Ability to effectively identify and communicate risks.
Experience with other analytical methodologies

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 container closure integrity (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

Benefits

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

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