Randstad USA
Overview
The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation, processing and analytical technologies. We create intellectual property through new formulation compositions, lean and smart manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will maintain as well as improve our technological equipment to expand the state-of-the-art and support the development of manufacturing processes for biologics. The candidate will help maintain and increase the state of operational excellence of our lab, working closely with analytical and formulation scientists to develop productive collaborations and communications with scientific and technical teams.
Responsibilities
Supporting the process development of parenteral formulations for biologics with a focus on antibody drug conjugates.
Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization). Screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
Act as the first point of contact for the operation of advanced NBE process technologies with emphasis on process unit operation (filling, filtration, lyophilization).
Perform continuous maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshoot technical issues on the machines.
Build strong relationships with other functional units (e.g., S&T, combination products, Analytical Development) and support/advice activities in collaboration with partners.
Optimize laboratory operations for efficient use of time and resources.
Document experimental data thoroughly in lab documentation systems, present concise scientific results, and author detailed scientific technical reports.
Ensure compliance with all applicable Company policies and procedures and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Qualifications Required
BS or MS in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4 years (BS) or 0-2 years (MS) of relevant experience, or significant technical/industrial experience in the field.
Solid understanding of unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
Experience in Microsoft Office (Excel, SharePoint, PowerPoint, and Word).
Preferred
Experience in laboratory systems (ELN) preferred.
Skills: Chemistry, Electronic Laboratory Notebook (ELN), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Chemistry Manufacturing and Controls (CMC)
Work specifics
Location: North Chicago, Illinois
Job type: Contract
Salary: $50.00 - 57.48 per hour
Work hours: 9 to 5
Education: Bachelors
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. We welcome people of all abilities and provide reasonable accommodations to make applications or interviews accessible. If you require accommodation, contact HRsupport@randstadusa.com.
Pay offered will be based on education, experience, location, job duties, certifications, etc. Randstad offers a comprehensive benefits package (medical, prescription, dental, vision, AD&D, life insurance, short-term disability, and 401K) based on eligibility.
This posting is open for thirty (30) days.
Seniority level: Not Applicable
Employment type: Contract
Job function: Research, Analyst, and Information Technology
Industries: Staffing and Recruiting
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The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation, processing and analytical technologies. We create intellectual property through new formulation compositions, lean and smart manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will maintain as well as improve our technological equipment to expand the state-of-the-art and support the development of manufacturing processes for biologics. The candidate will help maintain and increase the state of operational excellence of our lab, working closely with analytical and formulation scientists to develop productive collaborations and communications with scientific and technical teams.
Responsibilities
Supporting the process development of parenteral formulations for biologics with a focus on antibody drug conjugates.
Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization). Screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
Act as the first point of contact for the operation of advanced NBE process technologies with emphasis on process unit operation (filling, filtration, lyophilization).
Perform continuous maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshoot technical issues on the machines.
Build strong relationships with other functional units (e.g., S&T, combination products, Analytical Development) and support/advice activities in collaboration with partners.
Optimize laboratory operations for efficient use of time and resources.
Document experimental data thoroughly in lab documentation systems, present concise scientific results, and author detailed scientific technical reports.
Ensure compliance with all applicable Company policies and procedures and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Qualifications Required
BS or MS in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4 years (BS) or 0-2 years (MS) of relevant experience, or significant technical/industrial experience in the field.
Solid understanding of unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
Experience in Microsoft Office (Excel, SharePoint, PowerPoint, and Word).
Preferred
Experience in laboratory systems (ELN) preferred.
Skills: Chemistry, Electronic Laboratory Notebook (ELN), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Chemistry Manufacturing and Controls (CMC)
Work specifics
Location: North Chicago, Illinois
Job type: Contract
Salary: $50.00 - 57.48 per hour
Work hours: 9 to 5
Education: Bachelors
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. We welcome people of all abilities and provide reasonable accommodations to make applications or interviews accessible. If you require accommodation, contact HRsupport@randstadusa.com.
Pay offered will be based on education, experience, location, job duties, certifications, etc. Randstad offers a comprehensive benefits package (medical, prescription, dental, vision, AD&D, life insurance, short-term disability, and 401K) based on eligibility.
This posting is open for thirty (30) days.
Seniority level: Not Applicable
Employment type: Contract
Job function: Research, Analyst, and Information Technology
Industries: Staffing and Recruiting
Get notified about new Scientist jobs in North Chicago, IL.
Note: This description preserves the original content context while removing extraneous, non-essential boilerplate.
#J-18808-Ljbffr