Protara Therapeutics, Inc., named one of BioSpace's Best Places to Work, is hiring a Senior Scientist to play a pivotal role in analytical development. This position leads method development, qualification, and validation efforts to support both clinical and commercial manufacturing operations.
What You'll Do
- Lead development of innovative analytical methods and provide analytical support for manufacturing operations.
- Collaborate with Quality, Manufacturing, and Regulatory functions to achieve project objectives and timelines.
- Lead analytical method development, qualification, and validation for in-process, release, and stability testing to support clinical and commercial manufacturing.
- Develop phase-appropriate analytical control strategies, including specification setting, comparability assessments, and product characterization.
- Provide hands-on technical support during manufacturing campaigns, enabling analysts to execute in-process methods and troubleshoot analytical or process-related issues.
- Support real-time investigations for OOS/OOT/OOE, deviations, and adverse stability trends; contribute root-cause analysis and corrective actions.
- Ensure analytical readiness for GMP execution by guiding analysts on sample handling, method execution, and adherence to SOP's.
- Partner with Process Development, Manufacturing, Quality, and Regulatory teams to ensure smooth integration of new or revised analytical methods into batch manufacturing.
- Contribute analytical content for CMC sections of regulatory submissions (IND/IMPD/BLA/MAA), including method descriptions, validation packages, and responses to agency questions.
What We're Looking For
- Extensive experience in biologics analytical development, including method development, comparability, characterization, and phase-appropriate validation.
- Strong understanding of cGMP analytical execution, QC testing, and method lifecycle governance in a CDMO environment.
Work Mode
This is an onsite position located in Winston Salem, NC.
Protara Therapeutics is an equal opportunity employer.
