Scientist III

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

Target PR Range: 42-52/hr
*Depending on experience

Purpose:

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics and genetic medicine (proteins, conjugates, peptides etc.).

Seeking a highly motivated candidate for the position of Scientist III, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization.

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.

Qualifications:

• * Proven ability to solve critical scientific problems.
• * 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.
• * Hands-on 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.

Experience Level:

• * Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.