“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day Day Responsibilities:
- Excellent writing skills
- Capable of interfacing with multiple digital platforms simultaneously (MS teams, Document control systems)
- Knowledge of method transfer and validation in biotech/pharma required
- Ability to learn new systems quickly
- Write protocols and reports from templates
- Compile and verify data
- Statistical analysis of data
Candidate can sit anywhere within US & work any time zone: fully remote flexible hours within reason
3+ years of pharma/biotech experience
Biotech/ pharma experience required)
Ideal candidate Bachelors or Masters 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
Bachelor's or Master’s degree and 3 years of Operations or Scientific experience
"This posting is for Contingent Worker, not an FTE"
- Degree 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
- This Company is an 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.