Assistant Scientist I

Job Description

Job Summary:

• Our company’s Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of Client 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 combination product pipeline, inclusive of small molecule, biologics, and vaccine products.

Duties and 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.

Education and Experience:

• B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 0-1 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries.
• Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics.

Knowledge, Skills and Abilities:

• 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.
• Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in container closure integrity methods.
• 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.