Scientist - Biologics Formulation

Collabera; North Chicago (IL); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Paid parking/public transportation

Paid time off & holidays

Job summary

Collabera seeks an experienced Scientist III to lead biologics drug product formulation and process development. You will optimize formulations, characterize proteins, and support sterile unit operations to enable scalable manufacturing.

The role requires hands-on experience in biologics formulation, analytical characterization, and cGMP compliance, with a 12-month contract onsite in the United States.

Qualifications

• Bachelor’s degree with 8+ years, Master’s with 6+ years, or PhD with related experience.
• Hands-on biologics formulation development experience.
• Protein and solid-state characterization and biophysical methods.
• Experience in sterile manufacturing operations and technology transfer.

Responsibilities

• Lead biologics drug product formulation and process development activities.
• Design formulation characterization, optimization, and robustness studies.
• Characterize proteins by analytical/biophysical methods; ensure quality.
• Develop sterile unit operations: freeze-thaw, mixing, filtration, filling, lyophilization.
• Support scale-up and technology transfer to manufacturing sites.
• Apply DoE and multivariate analysis to optimize processes.
• Assess degradation mechanisms and stabilization strategies.
• Communicate plans, risks, and mitigations to stakeholders; ensure cGMP compliance.

Skills

Formulation development

DOE (Design of Experiments)

Multivariate analysis

Biologics characterization

Education

PhD in Pharmaceutics

MS in Pharmaceutical Sciences

Bachelor's in a related field

Tools

Statistical software

Job description

Pay Range: $50 to $55 an hour.

Job Mode: Onsite

Duration: 12 Months Contract, with potential extension based on performance and business

Job Summary

We are seeking an experienced Scientist III to lead biologics drug product formulation and process development activities. The ideal candidate will have strong hands on expertise in protein formulation, analytical and biophysical characterization, and sterile manufacturing process development. This role will focus on formulation optimization, process characterization, robustness studies, and protein stabilization strategies. The scientist will also support manufacturing scale up and technology transfer while applying advanced scientific and statistical approaches to solve complex technical challenges.

Key Responsibilities

• Lead the design and execution of biologics drug product formulation and process development activities.
• Design and perform formulation characterization, optimization, and robustness studies.
• Conduct analytical and biophysical characterization of proteins and apply solid state characterization methods.
• Develop and characterize sterile manufacturing unit operations, including freeze thaw, mixing, filtration, filling, and lyophilization.
• Support process scale up and technology transfer activities to internal and external manufacturing sites.
• Apply Design of Experiments and multivariate statistical analysis to optimize formulations and manufacturing processes.
• Evaluate biologics degradation mechanisms and implement appropriate stabilization strategies.
• Identify and resolve complex scientific challenges while communicating study plans, risks, and mitigation strategies to stakeholders.
• Ensure compliance with applicable cGMP, regulatory, safety, and quality requirements.

Required Qualifications

• Bachelor's degree with 8 or more years, Master's degree with 6 or more years, or PhD with relevant industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
• Hands on experience in biologics formulation development.
• Experience with analytical and biophysical characterization of proteins and solid state characterization methods.
• Experience in sterile manufacturing unit operations, including freeze thaw, mixing, filtration, filling, and lyophilization.
• Experience in process development, characterization, scale up, and technology transfer.
• Strong understanding of biologics degradation mechanisms and protein stabilization strategies.
• Hands on experience with Design of Experiments, multivariate statistical analysis, and data visualization tools.
• Proven ability to solve complex scientific problems.
• Understanding of cGMP, regulatory guidance, quality risk management, and drug product control strategies.

Preferred Qualifications

• Experience with protein therapeutics, antibodies, peptides, and conjugates.
• Experience supporting biologics drug product development from early development through manufacturing.
• Familiarity with advanced biologics formulation and process development technologies.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term disability insurance
• short-term disability insurance
• paid parking/public transportation
• (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)