Biologics Drug Product Scientist - Formulation & Process

Spectraforce Technologies, Inc.; North Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Scientist III to lead biologics drug product formulation and process development in North Chicago, IL. The role emphasizes design of experiments, scale-up, and technology transfer to manufacturing sites, with strict adherence to cGMP and quality practices.

The candidate will apply advanced analytical and biophysical characterization of proteins, stay current with industry advances, and communicate plans and risks to stakeholders in a timely manner.

Qualifications

• Hands-on experience with biologics formulation development.
• Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freez-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
• 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 development

Analytical & biophysical characteriz.

DoE & multivariate statistics

Data visualization tools

GxP regulatory guidance

Sterile manufacturing operations

Quality risk management

Education

Pharmaceutics/Pharmaceutical sciences/Chemistry/Chemical engineering degree

Job description

Spectraforce Technologies, Inc. seeks a Scientist III to lead biologics drug product formulation and process development in North Chicago, IL. The role emphasizes design of experiments, scale-up, and technology transfer to manufacturing sites, with strict adherence to cGMP and quality practices.

The candidate will apply advanced analytical and biophysical characterization of proteins, stay current with industry advances, and communicate plans and risks to stakeholders in a timely manner.