Senior Scientist

Protara Therapeutics, Inc. • Winston-Salem, NC

10d • Onsite

About The Position

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.
Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.
This role is required to be on site in Winston Salem, NC.
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.

Requirements

• 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.
• 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.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree