Scientist - Parenteral Process Development

Scientist III ::
Parenteral Process Development

Industry: Pharmaceutical/Biotechnology

Job Title:

Scientist III ::
Parenteral Process Development

Duration: 12 Months Contract (Possible Extension Based on Performance and Business Needs)

Location:

Lake County IL, 60064 Shift: Monday–Friday | 8 Hours per Day | Standard Business Hours

Pay Rate: $45.00 to $52.00 per hour

Product Development Science and Technology (PDS&T) is seeking a motivated Scientist, specifically for parenteral drug product process development and commercial site scale up and tech transfer.

The candidate will independently design and execute lab studies to develop robust manufacturing processes for clinical phase and commercial products.

This person will generate and analyze precise, reliable, and reproducible data in a timely manner, independently or under the direction of a more senior scientific leader.

This position will be an integral part of the product development and CMC teams.

Bachelor's Degree, or equivalent education, with typically 7 or more years' experience or Master's degree or equivalent education with 3 years' experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar area. (PhD with 0+ years' experience acceptable).

Supporting the process development of parenteral drug products.

Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), to develop robust dosage forms.

Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.

Demonstrated scientific writing skills and strong verbal communication skills.

Collaborative, lab-based scientific team that regularly partners with cross-functional groups to generate, share, and analyze experimental data.

Candidates will work with both self-generated and team-generated datasets to support scientific conclusions and project recommendations.

Primarily, a hands-on laboratory role with supporting responsibilities in data analysis, interpretation, and reporting.

Responsible for executing laboratory studies, compiling and analyzing experimental data, and generating scientifically sound conclusions.

Workload may vary between laboratory execution and data analysis activities based on project needs and priorities.

Candidates must be comfortable performing routine and advanced laboratory activities regardless of education level or years of experience.

• Perform laboratory activities including compounding, filtration, filling, and related drug product process development studies.
• Execute experiments using standard laboratory techniques and document results accurately.
• Conduct pH measurements and other analytical assessments to support formulation and process development activities.
• Compile, organize, and summarize experimental data into tables, reports, and presentations.
• Analyze data from multiple sources and independently draw conclusions and recommendations.
• Support project documentation and reporting using standard laboratory and business software tools.
• Demonstrated hands-on laboratory experience with compounding, filtration, and filling processes.
• Experience executing and interpreting laboratory experiments independently.
• Strong data handling skills including data compilation, organization, summarization, and interpretation.
• Proficiency with MS Excel and standard data analysis tools.
• Ability and willingness to work in a laboratory environment and perform hands-on experimental work on a regular basis.
• Experience with Karl Fischer titration.
• Familiarity with lyophilization processes.
• Experience using Electronic Laboratory Notebooks (ELN).
• Exposure to Minitab or other statistical analysis software.
• General understanding of HPLC or chromatography techniques.
• Experience with TSF is a plus.

• Strong laboratory scientist with demonstrated experience conducting experiments…