Job Description

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.

Job Tags

Similar Jobs