Position Details:

Top 3-5 skills, experience or education required for this position:

• 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.

Required Qualifications:

• Strong hands-on laboratory experience, specifically in compounding, filtration, and filling processes
• Experience conducting experiments and interpreting results independently
• Experience with pH measurement and general analytical lab techniques
• Strong data handling capabilities including data compilation, summarization, and interpretation
• Proficiency with basic data analysis tools (e.g., Excel, MS Office)
• Demonstrated scientific writing and verbal communication skills
• Experience with Karl Fischer titration
• Familiarity with lyophilization processes
• Exposure to TSF
• Experience with Electronic Lab Notebooks (ELN)
• Experience with Minitab or statistical analysis tools
• Basic understanding of HPLC or chromatography

Additional Expectations:

• Must be comfortable working in a lab-heavy environment regardless of education level (including PhD candidates)
• Ability to independently execute experiments and contribute to team-based data analysis
• Experience working with both individual and shared datasets in a collaborative environment