: Scientist, Process Development (JP5203)
11 Months with possible extension
3Key Consulting Inc. is recruiting for a Scientist with strong Biochemistry, Analytical Chemistry, Physical or Life Sciences background for global bio-pharmaceutical company.
The Process Development Scientist will be responsible for the strategy, execution, analysis and communication of method transfer and method validation protocol and report writing. This candidate will help to drive improving this process and effectively communicate results with internal and external partners across a global network.
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 clinical/commercial 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. This position works closely with representatives from key functions within Process Development, Manufacturing and Quality.
- OR Master’s degree and 4 years of Operations or Scientific experience
- OR Bachelor’s degree and 6 years of Operations or Scientific experience
- PhD in Biochemistry, Analytical Chemistry, Physical or Life Sciences
- Strong understanding and hands-on experience of methods within the following platforms Chromatography, Bioassay, PCR, - Microbiology, Immunoassay, CE, Gel, Device, Viral, and General
- Strong understanding and hands-on experience with method transfer and method validation processes with direct experience from a Pharmaceutical or Biotechnology Company.
- Advanced 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
Why the position is open:
This will augment current FTE roles to support extra protocols and workload. This is a new group at Amgen.
Top 3 Must Have Skill Sets
Will be heavily electronically dependent. Not a laboratory based role. Role will be the production of protocols, reports, documentation coordination, task tracking, document routing Two roles will focus on assisting larger team of Method transfer and validation group.
Day to Day Responsibilities:
- EDMQ: LIMS, LMES, Empower.
- Communication electronically
- Ability to follow understand documentation requirements/SOPS Knowledge of analytical methods and techniques used (not all, but some background) QC background desirable
Will work through task list daily on checkups with status, reporting out deliverables, writing protocols (heavy portion of job), coordinating deliverables from many team members
Employee Value Proposition:
This is a new group within Amgen that works with the entire global portfolio. This person would get to see variations of work implemented on a global scale. This would provide an immense learning opportunity, these skill sets are very transferable to other roles
Not able to communicate clearly. Not task driven. Not detail oriented
Phone screen followed by in-person