Scientist

Job Title: Scientist – II

Duration: 12 Months

Location: Rahway, NJ 07065

Qualifications:

Education/Work Experience Minimum Qualifications:

• 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

Required Experience | Knowledge | Skills:

• 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 Experience | Knowledge | 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.

Note:

• 100% lab based role.

• Buzz words: CCI, Container closure integrity, Vacuum decay, dye ingress, helium leak, laser headspace analysis, CO2 ingress, mass extraction, container validation, device verification, GMP, GXP, method development, method validation, USP <1207>, instron, medical device, tensile testing, auto-injectors, syringes, on-body injectors.

• Container Closure Integrity Testing: Closure integrity (CCI) is crucial for drug product sterility and stability. Container Closure Integrity Testing (CCIT), commonly referred to as leak detection, is a non-destructive packaging inspection system to maintain an aseptic barrier against potential contaminants.

Job Description:

Our company’s Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of novel 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.

Principal 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