: Scientist, Analytical Biochemist (JP7947)
Thousand Oaks, CA (Remote Work)
: Method Stewardship
: 12 months with likely extensions
Job posting date
3 Key Consulting is hiring a Scientist for a consulting engagement with our client, a leading global bio-pharmaceutical company.
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)
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.
- 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.
Top Must have Skill Sets:
- 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
Day to Day Responsibilities:
- 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.
Data verification of documents, drafting documents from templates (protocols/reports), organizing data for other team members to view, documentation heavy workload supporting team members.
Employee Value Proposition:
dynamic global organization with fast paced cutting edge.
Lack of any experience in biopharma industry (i.e. research only), or lack of experience with analytical methods, or document writing.
Lack of detail orientation, not able to quickly verbalize tasks
Lab based experience only (must have writing, data analysis).
Webex or Skype with video a must for all discussions - initial 1/2-hour screening meeting, followed by 1 or 2 one-hour meetings
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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