Reporting to the Senior Director, Analytical Chemistry and Drug Product Development, this individual will serve as an integral team member with exposure to multiple facets of business operations. The Scientist/Senior Scientist, Analytical Chemistry will be responsible for in-house method development and analysis, monitoring and evaluation of activities in a virtual manufacturing environment, and work closely with the organizations R&D team.
Major duties and responsibilities of the position include:
- Analytical method development
- Sample analysis (HPLC RP, SEC, IE; UV, LCMS)
- Physicochemical characterization
- Perform rudimentary bioconjugation/purification
- Review method transfer and method validation
- Develop specification criteria
- Track source documents (GMP controlled document system)
- Vendor CoA
- Vendor testing of critical intermediates
- Stability reports/data
- DS and DP release – Preparation of CoA
- Review stability protocols and reports (API and DP)
- Identify GAPS in Vendor internal systems and work with Vendor to improve internal systems for GMP compliance
Elicio is a growing organization based out of the Seaport District of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States.
This position does not allow for remote work and requires onsite attendance.
Education & Professional Experience
- PhD or MS/BS + 4-6 years
- Practical experience with ICH guidelines and USP
- Experience with operation and maintenance of HPLC-RP, -SEC, -IE, LCMS, UV
- Experience with microbial enumeration and endotoxin assessment a benefit
Busy office/laboratory environment with frequent deadlines and interruptions
Travel: Travel is not required
Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data. Work is performed exclusively in an office/laboratory environment.
To Apply: Please submit your resume to email@example.com using the job title in the email subject line.