A
Scientist
Advanced Bio-Logic Solutions Corp Arvada , CO 80001
Posted 3 weeks ago
Description:Note:
- Candidate can sit anywhere within US & fully remote flexible hours within reason, but need ability for working hours to have some overlap with colleagues on east and west coast, as needed
- 3+ years of pharma/biotech experience
- Biotech/ pharma experience required)
- Analytical method validation and transfer experience
- Ideal candidate with a bachelor's degree in Biochemistry, Analytical Chemistry, Physical or Life Sciences.
- Strong understanding of analytical 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 role in Commercial Process Development will be part of the global method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs.
- The role will provide technical support for critical large projects.
- Strong familiarity with the following method platforms is highly preferred: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General.
- Protocol and report authoring according to regulatory and industry guidelines (i.e., ICH) and data analysis will be a core activity in this role.
- This individual may support clinical and commercial locations throughout the company under the guidance of project leads.
- Master’s degree and 2 years of Operations or Scientific experience OR Bachelor’s degree and 4 years of Operations or Scientific experience
- 0+ Years w/ Relevant PhD OR equivalent (where applicable) 2+ Years w/ Relevant MS OR equivalent 4+ Years w/ Relevant BS OR equivalent Advanced and proficient understanding and use of technical principles, the OR ies, and concepts to perform expansive range of work in a role.
- Basic knowledge of related and adjacent disciplinary areas.
- Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences
- Strong understanding of 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 coordination of scientific results in a fast-paced, multi-disciplinary, team-based environment
- Demonstrated ability to manage projects cross functionally
- Demonstrated ability to propose and drive new scientific initiatives
- Analytical method validation and transfer experience
- Familiarity with analytical method technologies
- Self-starter with good communication skills
- Data verification of analytical method validation and transfer documents
- Data analysis including statistical analysis
- Drafting of analytical method validation and transfer plans, protocols, data appendices, and reports
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