Senior Scientist - Biologics Formulation & Drug Product Development

Randstad USA; North Chicago (IL); Sur place; USD 64 000 - 90 000; Plein temps

Résumé du poste

Randstad USA in North Chicago, IL is seeking a Senior Scientist to lead drug product formulation and process development for complex biologics, conjugates, and genetic medicines on a 1-year contract.

You will design and execute formulation development, characterization, and robustness studies, oversee scale-up and technology transfer for sterile drug products, and ensure cGMP compliance across internal and external sites.

Qualifications

• Degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field with 8+ years (BS), 6+ years (MS), or 0+ years (PhD) in biopharma industry.
• Proven hands-on formulation development and degradation pathway stabilization in biologics.
• Strong analytical/biophysical characterization and sterile unit operations experience.

Responsabilités

• Design and execute formulation development, characterization, and robustness studies for complex biologics pipelines.
• Lead process development, scale-up, and technology transfer for sterile drug product manufacturing to internal and external partner sites.
• Characterize sterile unit operations, including lyophilization, filtration, mixing, and filling.
• Apply DoE and multivariate analyses to elucidate degradation pathways and build robust stabilization strategies.
• Partner cross-functionally across R&D and manufacturing while upholding cGMP and quality standards.

Connaissances

Biologics Formulation

Drug Product Development

Lyophilization

Protein Characterization

Sterile Unit Operations

Technology Transfer

Design of Experiments (DoE)

Biophysical Characterization

cGMP

Filtration

Freeze-Thaw

Scale-Up

Formation

BS/MS/PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering or related field

Description du poste

Job Summary:

Accelerate your R&D impact with a premier global biopharmaceutical leader based in the thriving life sciences corridor of North Chicago, IL. We are seeking an accomplished, innovative Senior Scientist to spearhead drug product formulation and process development for advanced biologics, conjugates, and genetic medicines.

Location: North Chicago, IL

Job Type: 1 year contract

Pay: $55.89 per hour

Work Hours: Standard working hours

Education: Degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field: BS with 8+ years, MS with 6+ years, or PhD with 0+ years of biopharmaceutical industry experience.

Responsibilities:

• Design and execute formulation development, characterization, and robustness studies for complex biologics pipelines.
• Lead process development, scale-up, and technology transfer for sterile drug product manufacturing to internal and external partner sites.
• Characterize sterile unit operations, including freeze-thaw cycles, mixing, sterile filtration, vial filling, and lyophilization.
• Apply Design of Experiments (DoE) and multivariate analyses to elucidate degradation pathways and build robust stabilization strategies.
• Partner cross-functionally across R&D and manufacturing while upholding strict cGMP guidelines and corporate quality standards.

Qualifications:

• Degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field: BS with 8+ years, MS with 6+ years, or PhD with 0+ years of biopharmaceutical industry experience.
• Proven hands-on track record in biologics formulation development and degradation pathway stabilization.
• Strong expertise in analytical and biophysical protein characterization and solid-state methodologies.
• Demonstrated experience with sterile unit operations (lyophilization, filtration, mixing, filling) and tech transfer.
• Working knowledge of cGMP standards, regulatory guidelines, and Design of Experiments (DoE).

Skills:

Biologics Formulation, Drug Product Development, Lyophilization, Protein Characterization, Sterile Unit Operations, Technology Transfer, Design of Experiments (DoE), Biophysical Characterization, cGMP, Filtration, Freeze-Thaw, Scale-Up

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 [e-mail].

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.