Process Development Scientist

Role Summary

Process Development Scientist (Attribute Sciences).

Responsibilities

• Generate and analyze data from microanalytical investigations to identify and assess unknown or unexpected materials observed during manufacturing or development activities.
• Collaborate with internal and external partners across a global manufacturing and PD network to determine root causes and corrective actions for unexpected observations.
• Apply state-of-the-art spectroscopic and microscopic analytical tools for forensics investigations, ensuring documentation and compliance to meet cGMP standards.
• Support a chemo-metric spectroscopy-based analytical method platform, including data generation, monitoring, maintenance, and validation of chemo-metric models used in GMP manufacturing.

Qualifications

• Basic Qualifications: Bachelor‚Äôs degree with 4+ years of scientific or operations experience; or Master‚Äôs degree with 2+ years; or Doctorate degree.
• Preferred Qualifications: Advanced degree in Physical Chemistry, Analytical Chemistry, Chemical Engineering, Materials Science or related field; expertise in vibrational spectroscopies (FTIR, Raman); experience with microscopy and microanalytical techniques; ability to analyze analytical datasets; wet chemistry and sample handling knowledge; understanding of multivariate analysis and chemo-metric model training/validation/monitoring; strong GDP and cGMP compliance; experience in an investigative lab in pharma/biotech; excellent written and oral communication.

Skills

• Spectroscopy and microscopy techniques
• Data analysis and interpretation
• Documentation and compliance
• Chemo-metric modeling and multivariate analysis
• Communication and collaboration in cross-functional teams

Education

• As specified in Qualifications: Degree(s) as listed above.

Additional Requirements

• None beyond qualifications; travel/physical demands not specified as essential.