Job Description

The Scientist role in Commercial Process Development will be part of a team responsible for authoring method transfer and method validation protocols and reports for late stage and commercial programs. Technologies include the following method platforms: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. SOPs, protocols and reports will be authored according to regulatory and industry guidelines (e.g., ICH). This individual will support clinical and commercial locations throughout the company. This individual will be supporting fixed program deliverables ( e.g., compilation of templates, ensuring completion of document review and approvals, other) Preferred Qualifications: • Degree in Biochemistry, Analytical Chemistry, Physical or Life Sciences • Strong project scientific management experience Strong experience in analytical method transfers and validations • Strong technical writing skills • Strong on either or both of the following:

1. Organization of heavy workload, tracking project management skills (MS Project Preferred Excel-based project management is also desirable). Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment. Experience with document management systems
2. Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia). Experience with document management systems • Experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company. • Knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing May be familiar with ICH requirements for method validation/transfer

Qualifications

Basic Qualifications: • OR Bachelor’s degree and 5 years of Operations or Scientific experience • OR Associate’s degree and 10 years of Operations or Scientific experience • OR High school diploma / GED and 12 years of Operations or Scientific experience  

Additional Information

TOP 3 MUST HAVE SKILL SETS:

Very strong on either or both of the following two:

1. Organization of heavy workload, tracking project management skills (MS Project Preferred Excel-based project management is also desirable), communication skills (verbal, written), experience with document management systems
2. Strong scientific technical writing, review, strong method transfer and validation protocol and reporting writing experience. Experience with document management systems