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.

Job Overview: 

As our Medical Science Liaison (MSL), you’ll be part of our field-based medical team, reporting to the Director of Medical Science Liaisons.  The rare disease/oncology focused MSL develops on-going professional relationships with national and regional healthcare opinion leaders and other healthcare professionals in the hospital, institutional or clinical setting to provide medical and scientific support for company initiatives for TARA-002 (Lymphatic Malformations and NMIBC/oncology) and IV Choline Chloride.

Territories:

**We have 7 Medical Science Liaison (MSL) roles open to cover:

Florida

Ohio/Indiana

Texas

Arizona

Kansas City, Kansas and CO

Virginia, North Carolina and Tennessee 

Massachusetts

Essential Duties and Responsibilities:

• Identify and engage with top hospital-based clinicians and researchers to understand scientific needs and gather insights that support Protara strategies.
• Clinical Support: The MSL provides crucial, evidence-based data, and shares up-to-date treatment guidelines with hospital staff.
• Develop and maintain scientific, clinical, and technical expertise in Protara’s rare disease and uro-oncology portfolio through ongoing training and self-education, including attendance at relevant conferences, scientific workshops, and review of key publications and resources.
• Build territory plans for assigned geographies to include strategies and tactics for engagement with HCPs/key opinion leaders (KOLs) at their respective institutions and medical congresses.
• Support clinical trial execution including recruitment and site outreach as requested and communicate feedback to the Clinical Operations and Clinical Development teams.  Work collaboratively with Clinical Operations and Clinical Development teams as requested.
• Identify, establish, and maintain collaborative relationships with key investigators, institutional leaders, medical groups, and consortia.
• Provide scientific evidence and clinical trial information to healthcare professionals, clinical trial staff, and payors in a clear, scientifically accurate, and balanced manner.
• Increase awareness in the medical community of the company and enhance company interaction with thought leaders.
• Assist in training of new hire MSLs and, as appropriate. This will include assisting in design and implementation of effective training curricula and field resources that will promote the company’s reputation as a patient-oriented and science-driven organization; a reliable source of balanced medical information; and a partner in education and research with health care providers (HCPs) engaged in treating patients with rare and oncologic diseases.
• Support the development and implementation of advisory boards and other scientific meetings. Present scientific data at these forums as requested.
• Monitor the competitive landscape for specific therapeutic areas of interest to the company including current disease management strategies, approved products, new/emerging therapies, and differentiating features of approved/emerging competitor products. Contribute to CI plan for medical congresses. Communicate insights back to the company in an effective manner, especially those that may pertain to ongoing and planned clinical trials.
• Execute MSL activities with adherence to all related policies and standard operating procedures, and with regulatory and other ethical guidelines relevant to the pharmaceutical industry.
• Address unsolicited medical questions related to clinical trials, Investigator Initiated Research Studies, and other scientific exchange.

Qualifications:

• Advanced clinical/science degree or professional credentials required (MD/DO, PhD, PharmD, PA, NP, RN).
• 3-5+ years of experience in the biotech, start up or pharmaceutical industry, preferably in Medical Affairs, with 3+ years’ MSL experience and working with internal cross-functional teams.
• Oncology and rare disease experience are required.
• Must have experience in a hospital, institutional or clinical/pharmacy setting.
• Drive for personal excellence and accountability; set these expectations for the field team and promote the same for Medical Affairs colleagues.
• Business/enterprise mindset.
• Possess creative problem-solving skills.
• Strong interpersonal skills and demonstrated ability to work collaboratively in a dynamic, team-oriented environment.
• Strong organizational and business planning skills, including development of strategic plans and budgets, and adherence to targets.
• Ability to interact and communicate openly and effectively with Management, team members, HCPs/TLs, nurse coordinators and other clinical trial site staff, and payors. Experience conducting formal scientific presentations.
• Strong analytical skills, especially regarding understanding and interpreting scientific and clinical research and literature are essential.
• Adept, nimble, energetic, and comfortable in a fast-paced, dynamic, and collaborative environment.
• Capable of, and motivated by, taking a hands-on approach and "rolling up one's sleeves."
• Extensive travel (up to approx. 60%, US and international) with possible weekend congress obligations.

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 50% with some variations based on the demands of the business needs.

• Must be willing to travel to clinical trial sites, vendors as applicable, and 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.

*Salary Requirements are between $183,000 - $215,000. There is flexibility regarding salary based on years of experience and qualifications. We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

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 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.

Job Overview: 

The Executive Director/Vice President Trade, GPO and Patient Services will lead the Market Access team focused on US product distribution. They will work cross-functionally to establish and implement the distribution model that best supports access to Protara medicines while ensuring rapid availability of product to approved customers. From relationship initiation with US 3PL to order to cash implementation the ED/VP, Trade and GPO will lead the implementation for the launch of Protara Therapeutic’s products.  They will also manage the development and implementation of the Specialty Distribution and Specialty Pharmacy networks.  This role will also manage the program development and implementation of programs and contracts with group purchasing organizations (GPOs). This role will collaborate closely with members of Managed Access, Accounting, Legal, Finance, Information Systems, and Government pricing, Quality, and Pharmaceutical Operations.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Develop, implement and continual evaluation of the Trade Distribution model to meet the needs of Protara customers and patients. Identify any necessary changes or adjustments to the distribution model based upon new products, risk mitigation, and/or regulatory and legislative changes.
• Own relationships with channel partners; leverage available data to identify trends and opportunities to improve distribution efficiencies, address risks and manage budget.
• Oversee returns, adjusting transactions, new customer set-ups, credit limit requests, Trade notifications, and order reviews.
• In partnership with IT, ensure quality of ex-factory sales data.
• Oversee management of relationships and contracts with US Specialty Distributors.
• Partner with Supply Chain to manage product dating and maintain appropriate inventory at 3PLs.
• Liaise with Protara Legal team to ensure compliance to applicable laws and regulations.
• Serve as a subject matter expert as a member of New Product Launch teams.
• Partner with BD and Marketing to evaluate and recommend distribution strategies for new products.
• Oversee Trade policies and procedures, such as orders, returns, replacements, credit/rebill requests, inventory, and chargeback processing.
• Business travel by air, train, or car is required up to 50%

Supervisory Responsibilities: TBD.

 Education/ Qualifications:

• Bachelor’s degree required.
• Oncology/Rare Disease market experience; buy and bill product experience.
• 10+ years of relevant experience in the pharmaceutical or biotechnology industry.
• 5+ years of experience within Channel, Trade & Distribution; biotech/pharma experience.
• Experience managing a distribution network, preferably including specialty distribution and specialty pharmacies.
• In-depth knowledge of managed care and impact on product access.
• Strong team player that has customer service approach and is solution oriented.
• People management experience.
• Attention to detail and ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong oral and written presentation skills and executive presence.
• Strong vendor management skills.
• Understanding and ability to create appropriate, high-quality documentation.
• Advanced Microsoft Office skills with an emphasis on Excel and Powerpoint.

 Preferred Experience:

• Experience designing and implementing distribution strategy for first product to market biotech company.
• Experience establishing 3PL for first product to market biotech company.
• Experience with buy and bill products; medical benefit products.
• Contracting experience with GPOs, hospital systems and private practice providers.
• Leadership experience with a proven record of accomplishments, effectively leading cross functional teams.
• Experience with cross-functional teams in developing and executing strategic business plans.
• Demonstrated ability to think and act strategically to achieve team individual and team goals.
• Strong financial analytical skills including the ability to manage expenses and budget.
• Strong analytical thinking, problem solving skills, and attention to detail.
• Ability to interact with and influence Senior Management, peers, and other functions.
• Excellent listening, time management, organizational and interpersonal skills.
• Outstanding communication skills, including the ability to illustrate potential opportunities for our technologies’ applications.
• Strategic account management, previous experience in developing & implementing attainable account-specific business plans are required, as well as the ability to coach and support others in doing the same.

 Computer Skills:

• Must be proficient in MS Office Suite, with advanced skills in Excel.

Certificates, Licenses, Registrations: none required

 Other Skills and Abilities:

• Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail are essential
• It is essential that this individual demonstrates the ability to work with highly confidential information.
• Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Ability to work both independently and in a collaborative team setting.
• Proficiency in data mining/data extraction.
• Demonstrated experience working with and presenting to senior level management.
• Ability to work through uncertainty.

 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.

 This position requires travel; average travel for this position is 40-50% with some variation based upon the demands of the business imperatives.

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.

*Salary Requirements are between $315,000 - $320,000 (Executive Director) and $340,000 - $345,000 (Vice President) based on job-related knowledge, experience, education, and skills demonstrated.  We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

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.

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: 

• 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.