Top 3 Must Have Skill Sets:
Previous pharma/biotech lab experience
Excellent verbal and written communication skills
Can work independently with reliable follow through
Ideal candidate Master in Biochemistry, Analytical Chemistry, Physical or Life Sciences. Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
Biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Attribute Sciences group within Process Development is seeking a Scientist. The scientist will be responsible for the data verification, drafting, reviewing, and compilation for method transfer and method validation protocols and reports. The position will be a documentation centric role and the candidate will need to have experience with document management systems.
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 programs for the following method platforms: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocols and reports will be authored according to regulatory and industry guidelines (i.e., ICH). This individual will support clinical and commercial locations throughout the company.
Basic Qualifications: Pharma or Biotech
• Master’s degree and 3 years of Operations or Scientific experience OR Bachelor’s degree and 3 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
• Master in Biochemistry, Analytical Chemistry, Physical or Life Sciences
• Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
• Direct 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
• 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
• Demonstrated ability to critically analyze and interrogate various analytical data sets to drive and influence the process
• Demonstrated ability to propose and drive new scientific initiatives
Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
"This posting is for Contingent Worker, not an FTE"