Scientist, Drug/Device Combo Products

Merck is a leading company in the pharmaceutical industry, and they are seeking a Scientist for their Device Product & Process Development Team. The role involves developing and validating analytical methods for container closure integrity in combination products, providing technical leadership, and collaborating with cross-functional teams to ensure compliance with industry standards. 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 Skills 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 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 Good technical, communication (oral and written), interpersonal, and teamwork skills Ability to effectively identify and communicate risks Experience with other analytical methodologies Benefits Medical Dental Vision healthcare and other insurance benefits (for employee and family) Retirement benefits, including 401(k) Paid holidays Vacation Compassionate and sick days Company Overview Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases. It was founded in 1891, and is headquartered in Rahway, New Jersey, USA, with a workforce of 10001+ employees. Its website is