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 based on site in Winston Salem, North Carolina.

The Vice President, Quality and Regulatory will report to the Chief R&D Officer and will assume leadership of the following duties:

Job Overview: 

• Oversight and management of all quality systems. 

• Sign-off of batch and material release documentation. 

Essential Duties and Responsibilities: 

• Lead and evolve the CDMO’s Quality Compliance strategy for applicable GMP manufacturing operations, ensuring readiness for both clinical and commercial production. 

• Ensure full alignment with GMP, GLP, and GCP standards, which govern manufacturing, preclinical testing, and clinical‑trial‑related material production, respectively. 

• Ensure regulatory compliance across manufacturing, documentation, data integrity, and quality systems per globally recognized regulatory standards. 

• Oversee QA, QC, and Quality Systems, including deviations, CAPAs, change controls, risk management, stability oversight, and analytical method validation support. 

• Build a robust Quality Management System (QMS) aligned with CDMO best practices: SOP governance, GMP adherence, and ongoing process monitoring. 

• Partner closely with Technical Operations, Regulatory Affairs, and Analytical Development to ensure that process development, and manufacturing adhere to quality standards. 

• Support phase‑appropriate Quality/Regulatory needs including documentation, regulatory submissions, and quality governance. 

Qualifications: 

• Proven expertise in audit management, inspection readiness, CAPA governance, deviation management, and quality risk management systems. 

• Strong command of global regulatory frameworks, including expectations in data integrity, documentation, and GxP compliance. 

Education and/or Experience: 

• Advanced degree (Master’s or PhD) in Pharmaceutics, Biochemistry, Biochemical Engineering, Microbiology, or related life science fields preferred.  

• 20+ years of progressive Quality leadership experience in GMP‑regulated biologics/pharmaceutical manufacturing, including microbial or bacterial system experience. 

• Significant experience in clinical and commercial readiness, including scale‑up, process validation, regulatory inspections, and marketing ‑authorization support. 

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.

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.

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: 

• 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. 

 Essential Duties and 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 and/or 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:  

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.

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: 

• Development and validation of analytical test methods. 

• Oversight of raw material, in-process and finished product testing. 

 Essential Duties and 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. 

 Qualifications: 

• 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 ilate‑stage (Phase 3/commercial) analytical programs. 

 Education and/or Experience: 

• 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 

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.