Executive Director/Vice President, Analytical at Protara Therapeutics

Winston Salem, North CarolinaFull-timeCMCPosted about 2 months ago

About the Role

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:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Development and validation of analytical test methods. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1">Oversight of raw material, in-process and finished product testing. </li> </ul>  Essential Duties and Responsibilities:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="24" data-aria-level="1">Act as the analytical lead for CDMO engagements, providing oversight of analytical method development, validation, transfer, and routine testing activities. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="25" data-aria-level="1">Lead phase‑appropriate analytical development strategies across the lifecycle, from early development through late‑stage / commercial programs. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="26" data-aria-level="1">Provide scientific leadership for analytical characterization, release, stability, comparability, and control strategies for biologics (drug substance, drug product, intermediates). </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="27" data-aria-level="1">Build and oversee an analytical organization responsible for method development, qualification, validation, specifications, reference standard qualification, and stability program setup. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="28" data-aria-level="1">Oversee CDMO execution of QC testing, stability testing, reference standard/reagent programs, and analytical gap remediation. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="29" data-aria-level="1">Partner with process development, manufacturing, quality, regulatory, and supply chain to ensure analytical readiness for clinical and commercial manufacturing. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="30" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="31" data-aria-level="1">Author, review, and contribute analytical content for regulatory submissions (IND, IMPD, CTA, BLA, MAA), including responses to health authority inquiries. </li> </ul>  Qualifications:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="32" data-aria-level="1">Extensive experience in biologics analytical development, including method development, qualification/validation, and lifecycle management. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="33" data-aria-level="1">Deep understanding of analytical characterization techniques (purity, identity, potency, stability, CQAs) for microbial systems.  </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="34" data-aria-level="1">Demonstrated expertise supporting ilate‑stage (Phase 3/commercial) analytical programs. </li> </ul>  Education and/or Experience:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="35" data-aria-level="1">Advanced degree (MS/PhD) in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related field, consistent with analytical leadership roles in biologics </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="36" data-aria-level="1">10–20+ years of analytical development and QC experience in biologics, with increasing leadership responsibility </li> </ul>   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. <ul> <li>Must be willing to travel to New York City office as needed.</li> </ul> Work Environment:   The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. <ul> <li>No specific work demands.</li> </ul> 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 <ul> <li>Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.</li> <li>Company-wide dedication to profoundly impacting patients’ lives.</li> <li>Amazing culture whereby our core values and behaviors are shared cross-functionally.</li> <li>Flexible working hours/schedule.</li> <li>Generous Paid Holidays and Unlimited PTO.</li> </ul> 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.

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