Scientist - II (Associate) # Container closure integrity testing

My name is Gaurav and I am a recruiter with Net2Source Inc. I saw your profile on one of the job boards and our direct client is looking to hire a Scientist - II (Associate) # CCIT Only in their growing team.

Please find below the job description.

Title : Scientist - II (Associate) # Container closure integrity Testing

Location : Rahway NJ

Duration : 12 months

No Benefits

Job Description:

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

Quals--

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.

Thanks

Gaurav Gupta

Sr. Pharma Recruiter

gaurav.gupta@net2source.com

(201) 331-8302