Protara Therapeutics · 1 month ago
Associate Director, Director Senior Scientist(Analytical)
United States
Full-time
Remote
Lead/Staff, Director/Executive
8+ years expProtara Therapeutics is a clinical-stage biotechnology company focused on advancing therapies for cancer and rare diseases. The role involves leading the development of innovative analytical methods and providing analytical support for manufacturing operations, collaborating with various teams to achieve project objectives.
BiotechnologyHealthcareHealth CareTherapeutics
Responsibilities
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
Qualification
Required
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
Ability to summarize complex analytical/technical issues clearly and provide practical guidance to support manufacturing operations
Bachelor's, Master's, or PhD in Biochemistry, Biology, Analytical Chemistry, Biotechnology, or related Life Sciences field
8–15+ years of experience in analytical method development, QC method lifecycle management, or process‑analytical support within biologics/bioprocessing. (Director roles typically require extensive expertise.)
Hands‑on experience with GMP batch support, including method troubleshooting, analyst guidance, and real‑time manufacturing support
Experience contributing to regulatory filings and supporting clinical → commercial analytical readiness
Benefits
Flexible working hours/schedule.
Generous Paid Holidays and Unlimited PTO.
Company
Protara Therapeutics
Protara Therapeutics develops transformative therapies for people with cancer and rare diseases with limited treatment options.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$224.15MKey Investors
Acorn Bioventures,RA Capital Management
2025-12-04Post Ipo Equity· $75M
2024-12-09Post Ipo Equity· $100M
2024-04-05Post Ipo Equity· $45M
Leadership Team
Jesse Shefferman
Chief Executive Officer
Kristy (Coker) Rosse
SVP & Chief People Officer
Recent News
MarketScreener
2026-06-30
2026-05-28
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