Are you ready to play a pivotal role in the development of life-saving therapeutics? As a Research Analyst II within the Global Material and Parenteral Packaging Science team, you will be at the forefront of Product Development Science & Technology. You will drive the advancement of strategic pipeline assets, including monoclonal antibodies and antibody-drug conjugates, by ensuring the integrity and performance of innovative Container Closure Systems (CCS).
This role is based at a world-class, state-of-the-art research and development campus in North Chicago, designed to foster high-level scientific collaboration and technical innovation. You will leverage cutting-edge techniques to characterize vials, prefilled syringes, and cartridges, directly impacting the quality of biotechnological products that reach patients worldwide.
location: North Chicago, Illinois
job type: Contract
salary: $32.00 - 37.89 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Prepare, execute, and evaluate experiments for the development of container closure systems for parenteral drug products, including vials, pre-filled syringes, cartridges, and lyophilizates.
- Perform technical evaluations and implement Container Closure Integrity (CCI) and process methods, driving continuous improvement based on regulatory requirements and holistic strategies.
- Conduct performance analyses using force analyzers and assist in the development and validation of analytical methods.
- Maintain laboratory equipment by ensuring strict adherence to maintenance schedules, proper documentation, and personnel training.
- Provide technical support for landscaping programs of innovative CCS, including the characterization of new materials through various CCI techniques.
- Collaborate with internal partner labs, external vendors, and manufacturing sites to coordinate the procurement of materials, equipment, and services.
- Document all experimental work according to GxP standards and author scientifically sound reports, risk assessments, and development summaries for regulatory submissions.
qualifications:
Required Skills
- Education: Bachelor's Degree in Pharmacy, Biology, Biotechnology, Chemistry, Process Engineering, Material Sciences, Physics, or a related scientific discipline.
- Experience: Typically 2+ years of relevant experience with a Bachelor's degree, or a Master's degree in a related field.
- Technical Knowledge: Proven scientific understanding of parenteral drug product development and Container Closure Integrity (CCI) test methods.
- Compliance: Ability to document work within a GxP environment and follow internal procedural requirements.
- Communication: Strong verbal and written communication skills with the ability to author comprehensive technical reports.
- Experience with force analyzers and performance analysis of delivery systems.
- Familiarity with the development of monoclonal antibodies (mAbs) or antibody-drug conjugates (ADCs).
- Proactive approach to lab management and equipment maintenance.
- Proven ability to manage multiple projects concurrently and resolve priority conflicts within a team setting.
skills: Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
