Principal Quality Control Scientist (Chemistry)

Sr Quality Control Scientist (Chemistry) – Technical Resources

Responsibilities:
- Perform assay development, characterization, optimization, transfer, validation, and investigations for QC.
- Provide technical support, guidance, and supervision for release, stability, and in-process testing and assay development.
- Conduct assay development/validation for QC.
- Review new test procedures and assays.
- Evaluate and introduce new methodologies/techniques when needed.
- Facilitate assay transfer from R&D and to business partners; organize transfers internally and externally.
- Set product specifications.
- Participate in technical troubleshooting and problem investigation.
- Review analytical development reports, assay/process validation reports, and other technical documents for technical correctness and regulatory compliance.
- Participate in training programs for analysts.

Qualifications / Required / Preferred:
- In-depth knowledge of HPLC-based assays.
- BS in Chemistry, Biochemistry, Biology, or related field; 6+ years of relevant experience. Higher-level degree preferred.
- Experience with cell or gene therapy in a biopharmaceutical environment strongly preferred.

Skills:
- Strong written and verbal communication skills.
- Team player; able to work with diverse people on multiple tasks.
- Troubleshooting mindset and ability to handle constant change.
- Ability to mentor/train others on systems, processes, and problem solving.
- Fast-paced, flexible, and able to learn quickly with ambiguous challenges.

Application:
- Apply now.