Title: Assistant Scientist - I

Duration: 12 months

Location: Rahway, NJ

Pay: $32.00 - $ 36.00 /hr on W2

Job Description

• Our Client's Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of 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
• 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
• Candidate will develop methods for our 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
  
  

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
• 0-1 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries
  
  

Required Experience | Knowledge | Skills

• 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, troubleshoot assays, author and review technical documents
• Excellent organizational skills to manage multiple projects
  
  

Preferred Experience | Knowledge | Skills

• Experience in a Good Manufacturing Practices (cGMP) laboratory environment working with large molecules (vaccines, biologics)
• Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics
• Familiarity with CCIT technologies including 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), and metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], high-speed imaging)
• Strong technical, oral and written communication, 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 , instron, medical device, tensile testing, auto-injectors, syringes, on-body injectors

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

Why Work With Us

• At Net2Source, we believe everyone has an opportunity to lead
• We value your perspective and your ability to create value
• Inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment
• Opportunities to have a strategic impact, innovate, and grow professionally
• We assist clients with new skilling, talent strategy, leadership development, employee experience, and transformational change management
  
  

Equal Employment Opportunity Statement

• Net2Source is an Equal Opportunity Employer
• We do not discriminate based on age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation
• Our diversity makes us more innovative, competitive, and creative
• All employment decisions are made without regard to protected characteristics under federal, state, or local law
  
  

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• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing Industry Analysts (2020, 2019, 2020)
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• INC 5000 Fastest growing for 8 consecutive years (only 1.26% of companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
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• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1 (Act1 Group)