Senior Director/Executive Director, Biologics Manufacturing

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.

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

Job Overview: 

Oversight of manufacturing in conjunction with VP, Quality/Regulatory. 

 Essential Duties and Responsibilities: 

• Serve as the primary technical steward for manufacturing processes, overseeing process performance, troubleshooting, and technical decision‑making. 

• Oversee the full process validation lifecycle (PPQ, CPV), including establishing ongoing Continued Process Verification (CPV) programs for commercial products. 

• Act as the primary relationship manager for CDMO manufacturing teams, facilitating meetings, resolving issues, and maintaining transparency on timelines and deliverables. 

• Collaborate with Quality Operations in leading complex manufacturing investigations, root‑cause analyses, and CAPA implementation to ensure reliable process performance. 

• Drive process optimization, yield improvement, cost reduction, and adoption of new technologies where appropriate. 

• Build, mentor, and manage a high‑performing MSAT/Manufacturing team, fostering scientific excellence, accountability, and collaborative culture. 

 Qualifications: 

• Deep technical expertise in biologics manufacturing, including upstream/downstream processes, scale‑up, process validation, and lifecycle management. 

• Strong understanding of cGMP requirements, global regulatory standards, and commercial manufacturing expectations for biologics. 

• Demonstrated success managing CDMO manufacturing operations, including tech transfer, performance monitoring, and deviation management. 

• Proven ability to lead multidisciplinary teams, manage complex manufacturing programs, and implement strategic improvements. 

 Education and/or Experience: 

• Ph.D. or M.S. in Biochemical Engineering, Biotechnology, Biologics Manufacturing, or related discipline; Ph.D. preferred for executive‑level MSAT/manufacturing leadership roles. 

• 15+ years of biologics manufacturing experience, with at least 7+ years in a leadership role within MSAT, Technical Operations, or Manufacturing. 

• Significant experience supporting late‑stage and commercial manufacturing, including PPQ, CPV, and managing regulatory inspections 

 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.