Senior Biologics Formulation & Process Scientist

Planet Pharma; North Chicago (IL); On-site; USD 58,000 - 72,000; Full time

Job summary

Planet Pharma in North Chicago, IL is seeking a Scientist III for Biologics Drug Product Development to lead formulation and process development for biologics and to oversee characterization studies.

The role requires hands-on experience with DoE, analytical methods, regulatory guidance, and scale-up/tech transfer to manufacturing sites, with a focus on robust product development and adherence to cGMP and safety standards.

Qualifications

• Hands-on experience with biologics formulation development.
• Analytical and biophysical characterization of proteins.
• Knowledge of biologics degradation mechanisms and stabilization strategies.
• Experience with Design of Experiments (DoE) and multivariate statistical analyses.
• Understanding of cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freez-thaw, mixing, filtration, filling, and lyophilization).
• Experience with quality risk management and drug product control strategies.

Responsibilities

• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Keep abreast of the latest advances in biologics formulation and process technologies.
• Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
• Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
• Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

Skills

Biologics formulation

Process development

Analytical characterization

DoE

cGMP compliance

Technology transfer

Education

Bachelor's degree

Master's degree

PhD

Job description

Planet Pharma in North Chicago, IL is seeking a Scientist III for Biologics Drug Product Development to lead formulation and process development for biologics and to oversee characterization studies.

The role requires hands-on experience with DoE, analytical methods, regulatory guidance, and scale-up/tech transfer to manufacturing sites, with a focus on robust product development and adherence to cGMP and safety standards.