Overview In this role, you will drive scale-up from laboratory to production, applying DOE and analytical methods to support process startups. You will work in a GMP/cGMP environment, collaborate with teams, and provide training and technical guidance. Your work will include method development, tech transfer, and documentation to enable rapid progression from lab to full-scale operations. This position offers impact on process optimization in a regulated setting and cross-functional collaboration within a leading pharma environment.
Responsibilities- Scale up operations from lab to startup and then to full production
- Design of Experiments planning and execution
- Author test methods, transfer studies, and site-required reports
- Assist investigations and troubleshooting of methods
- Provide training and guidance to staff in areas of expertise
- Support startup of processes and project management from startup to full scale
- Work in GMP and cGMP environments with strict safety and method requirements
- Participate in team-based and independent lab work with scientific assessment of progress
Key requirements- BS or MS in Science with 4+ years in a related industry
- Experience with analytical instrumentation in a lab setting
- Proficiency with Word, Excel, and Outlook
- Experience writing and revising testing methods, protocols, and reports
- GMP environment experience and MS Project familiarity
- Hands-on experience with HPLC and detection methods; colorimetric assays also relevant
- Ability to document work using a documentation system and author protocols/reports
- Strong verbal and written communication and collaborative skills
- Good communication (verbal and written)
- Team-oriented and collaborative
- Ability to train and mentor staff
- HPLC instrumentation and detection methods
- Other analytical methods including colorimetric assays
- Design of Experiments (DOE)
