Senior Director/Executive Director/VP, Facility Oversight

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.

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.

The Senior Director, Executive Director, Vice President,  Facility Oversight will report into the Chief R&D Officer. 

This role is based on site in Winston Salem, North Carolina.

Job Overview: 

• Oversight and management of facility operations and upgrades. 

• Oversight and management of facility testing and qualifications. 

 Essential Duties and Responsibilities: 

• Provide ongoing performance monitoring of key facility and operational KPIs across manufacturing sites, including schedule adherence, batch performance, deviation trends, and inspection readiness. 

• Oversee operational execution related to scheduling, manufacturing, quality, finances, supply chain, and regulatory coordination, supporting both clinical and commercial production requirements. 

• Serve as primary relationship manager and point of escalation with CDMO partners, facilitating communication, issue resolution, and alignment across technical operations, quality, supply chain, and regulatory affairs. 

• Ensure that CDMOs adhere to GMP standards, supplier control expectations, and structured oversight programs to prevent supply interruptions, deviations, or regulatory findings.  

• Ensure compliance with expectations outlined in ICH Q10 Pharmaceutical Quality System, including quality agreements, risk‑based assessments, and ongoing monitoring of contractor suitability. 

 Qualifications: 

• Deep expertise in biologics/vaccine manufacturing processes, including technical rigor needed for complex biologics, vaccines, or microbial systems used in drug substance and drug product manufacture 

• Strong understanding of GMP requirements, supplier control, and CDMO oversight, including audit readiness, risk‑based oversight frameworks, and facility qualification expectations 

• Experience managing complex GMP manufacturing programs, including scheduling, budgeting, cross‑functional coordination, and oversight of clinical and commercial production. 

• Ability to lead structured technology transfers, resolve investigations, and maintain robust process performance across multiple CDMO sites 

 Education and/or Experience: 

• Bachelor’s or advanced degree in Biology, Life Sciences, Engineering, or related scientific discipline, consistent with external CDMO‑oversight manufacturing leadership roles. 

• 8–20+ years of relevant biopharmaceutical manufacturing or CDMO management experience, depending on seniority (Director → VP), with increasing responsibility across GMP production, external manufacturing, or technical operations. 

 

Physical Demands:  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 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: 

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Why You’ll Love Working at Protara

• 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.

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.