Scientist-(Scientific Writing & Technical documentation)–Remote

Contract

Company Description

Bio-Tech

Job Description

Candidate can sit anywhere within US & work any time zone: fully remote 3+ years of pharma/biotech experience

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. Preferred Qualifications:

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

Qualifications

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

Additional Information Top 3 Must Have Skill Sets:

Scientific writing skills, reviewing and writing technical documentation for analytical methods. Project management skills Pharma or Biotech experience Independent worker, with organization of heavy workload, communication/ electronic platform skills (verbal, written). Ability to conduct very detail oriented work – data verification, protocol writing, reporting drafting, data review.