Associate Director, Director Senior Scientist(Analytical)

Company Overview

Protara Therapeutics is a clinical‑stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA‑002, an investigational cell‑based therapy in development for the treatment of non‑muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA‑002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette‑Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Job Overview

• Lead development of innovative analytical methods and analytical support of manufacturing operations.
• Collaborate with Quality, Manufacturing and Regulatory functions to achieve project objectives and timelines.

This role is required to be on site in Winston Salem, NC.

Essential Duties & 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.

Qualifications

• 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.

Education & Experience

• 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.

Physical Demands

Average travel for this position is 20% with some variations based on the demands of the business needs. Must be willing to travel to New York City office as needed.

Work Environment

No specific work demands.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

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