Quality Control Scientist
About The Position
We are looking for a Quality Control Scientist in the Technical Resources Department. This position performs assay development, characterization, optimization, transfer, validation, and investigations for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. As a QC Scientist for Chemistry in the Technical Resources Department, a typical day might include the following: Performs assay development/validation for QC. Reviews new test procedures and assays. Evaluates and bring in new methodologies/techniques when needed. Facilitate assay transfer from R&D and to business partners Organize analytical assay transfer internally and externally. Set product specification. Participates in technical troubleshooting and problem investigation. Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. Participates in training programs for analysts.
Requirements
- BS in Chemistry, Biochemistry, Biology, or a related field
- 4+ years of relevant experience
- In-depth knowledge with HPLC based assays.
- Ability to deal with technical issues, troubleshooting, and constant change
- Strong written and verbal communication skills
- Ability to mentor and train others on systems, processes and problem solving
- Ability to work in a fast-paced environment and are flexible to changing requirements
- Ability to take on new and sometimes ambiguous challenges and learn quickly
Nice To Haves
- Higher level degree preferred.
- Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred.
Responsibilities
- Performs assay development/validation for QC.
- Reviews new test procedures and assays.
- Evaluates and bring in new methodologies/techniques when needed.
- Facilitate assay transfer from R&D and to business partners
- Organize analytical assay transfer internally and externally.
- Set product specification.
- Participates in technical troubleshooting and problem investigation.
- Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
- Participates in training programs for analysts.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
