Product Development Science and Technology (PDS&T) is seeking a highly motivated, self-driven scientist, specifically with knowledge and experience in aseptic filling of parenteral products, process development and commercial site scale up and tech transfers. The candidate is additionally expected to be familiar with and comply with regulatory standards within pharmaceutical manufacturing operations.
The candidate will independently design and execute lab studies to develop robust manufacturing processes for clinical phase and commercial products. This person will generate and analyze precise, reliable, and reproducible data in a timely manner, independently or under the direction of a more senior scientific leader. This position will be an integral part of the product development and CMC teams.
location: North Chicago, Illinois
job type: Contract
salary: $50.00 - 57.48 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Supporting lab studies for process development and technology transfer of parenteral drug products. Modalities can be synthetic molecules and biologics, including antibody drug conjugates (ADCs).
- Design and execute lab studies evaluating the stability (chemical & physical) of biologics against solution conditions and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), to develop robust dosage forms and manufacturing processes.
- Design, execute and interpret critical lab experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
- Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
- Set and meet experimental timelines. Effectively organize and present scientific plans and data.
qualifications:
- Bachelor's Degree, or equivalent education, with typically 7 or more years' experience or Master's degree or equivalent education with 3 years' experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar area.(PhD with 0+ years' experience acceptable).
- Experience in laboratory environment in the area of pharmaceutical manufacturing or process development
- Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
- Demonstrated ability to learn, understand and master new experimental techniques.
- Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
- Understanding of regulatory requirements for injectable products
- Demonstrated scientific writing skills and strong verbal communication skills.
skills: Regulatory Affairs Operations, Aseptic Processing, Chemistry Manufacturing and Controls (CMC)
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.
