Protara Therapeutics · 2 months ago
Executive Director/Vice President, Analytical
United States
Full-time
Remote
Director/Executive
10+ years expProtara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. The Executive Director/Vice President, Analytical will lead the development and validation of analytical test methods, oversee testing processes, and provide scientific leadership for analytical characterization and regulatory submissions.
BiotechnologyHealthcareHealth CareTherapeutics
Responsibilities
Act as the analytical lead for CDMO engagements, providing oversight of analytical method development, validation, transfer, and routine testing activities
Lead phase‑appropriate analytical development strategies across the lifecycle, from early development through late‑stage / commercial programs
Provide scientific leadership for analytical characterization, release, stability, comparability, and control strategies for biologics (drug substance, drug product, intermediates)
Build and oversee an analytical organization responsible for method development, qualification, validation, specifications, reference standard qualification, and stability program setup
Oversee CDMO execution of QC testing, stability testing, reference standard/reagent programs, and analytical gap remediation
Partner with process development, manufacturing, quality, regulatory, and supply chain to ensure analytical readiness for clinical and commercial manufacturing
Provide analytical governance across internal and external teams, acting as a technical SME for drug substance (DS), drug product (DP), intermediates, and in‑process control
Author, review, and contribute analytical content for regulatory submissions (IND, IMPD, CTA, BLA, MAA), including responses to health authority inquiries
Qualification
Required
Extensive experience in biologics analytical development, including method development, qualification/validation, and lifecycle management
Deep understanding of analytical characterization techniques (purity, identity, potency, stability, CQAs) for microbial systems
Demonstrated expertise supporting late-stage (Phase 3/commercial) analytical programs
Advanced degree (MS/PhD) in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related field, consistent with analytical leadership roles in biologics
10–20+ years of analytical development and QC experience in biologics, with increasing leadership responsibility
Benefits
Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
Company-wide dedication to profoundly impacting patients’ lives.
Amazing culture whereby our core values and behaviors are shared cross-functionally.
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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