About the Role - The candidate will develop methods for our company's combination product pipeline, inclusive of small molecule, biologics, and vaccine products.
Responsibilities
- 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
Required Skills
- B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 2-4 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries.
- Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in container closure integrity methods.
- 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 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
- Familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT Zeiss , Optical microscopy Keyence , high-speed imaging)
- Good technical, communication (oral and written), interpersonal, and teamwork skills.
- Ability to effectively identify and communicate risks.