Scientist – Biotech (JP7400)
Cambridge, MA - REMOTE
+ months (with likely extensions)
3 Key Consulting is hiring a Scientist for a consulting engagement with our client, a leading global biopharmaceutical company.
The scientist will be responsible for the compilation and drafting of method validation protocols and reports for raw material methods. 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 and commercial programs. Technologies can include chromatography, spectroscopy, and compendia based methods. A scientific background in Quality and/or Analytical Sciences will be appropriate. This individual will be supporting fixed program deliverables by ensuring protocols and reports are completed for developed and validated methods.
Top Must-Have Skill Sets:
- PhD - 1+ years within a Pharma or Biotech environment
- OR Master’s degree and 3 years of Operations or Scientific experience within a Pharma or Biotech environment
- OR Bachelor’s degree and 5 years of Operations or Scientific experience within a Pharma or Biotech environment
- Looking for industry - non academia experience.
- Strong experience with method validation protocol and report writing from a Pharmaceutical or Biotechnology area.
- Experience in method validation protocols and reports meeting ICH criteria
- Strong project scientific management experience
- Strong technical writing skills
Day to Day Responsibilities:
- Experience in method validation document writing for pharma regulations
- Experience with working remotely and delivering
- Experience within biopharma company with analytical methods
Produce method validation protocol/reports. Data verify information on documents. Understand DOE for analytical method validations.
Employee Value Proposition:
Insight to work on method validation transfers across all methods across the organization
Lacks communication skills. Lacks knowledge of method validation. Lacks awareness of analytical methods.
Phone screening followed by Skype
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.