The Biologics Drug Product Development team develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person to support Developability and Formulation Development. The candidate will support early-stage assessment of candidates coming out of the Discovery pipeline, as well as the design and development of stable and robust drug product formulation for biologics used in clinical trials. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, and Process R&D.
location: North Chicago, Illinois
job type: Contract
salary: $40.00 - 44.39 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Support the biologics characterization and stability assessment activities of the assigned biologics, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
- Execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
- Prepare concise and sound scientific presentations of experimental results to the management and assist in authoring detailed scientific technical reports.
- Stay current with the scientific literature and support new scientific initiatives.
qualifications:
Required Skills:
- Extensive hands-on expertise using analytical methods for chemical and structural characterization of biologics (e.g., HPLC, UPLC, capillary electrophoresis, particle analysis, biophysical techniques like UV-vis, DLS, DSC).
- Scientific understanding of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins, including their degradation and stabilization.
- Strong laboratory skills in formulation development for monoclonal antibodies and antibody constructs/conjugates (excipient selection, high throughput assays).
- Solid understanding of aseptic manufacturing unit operations (bulk freeze thaw, compounding/mixing, filtration, filling, lyophilization).
- Excellent oral communication skills in a scientific setting.
- Strong technical writing and documentation competencies.
- BS or MS in a scientific field (4 years of relevant experience for BS, 2 years for MS).
- Experience with developing formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
- Ability to work independently and manage multiple tasks with short lead times.
- Strong problem-solving abilities and a proactive approach to solutions.
- Leadership competencies such as fostering collaboration, creating a learning environment, and embracing innovation.
skills: CMC, HPLC, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
