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
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