CMC Development Manager at VenatoRx Pharmaceuticals
Malvern, PA, US

Venatorx Pharmaceuticals is a private pharmaceutical company focused on the discovery and development of novel anti-infectives to treat multi-drug-resistant (MDR) bacterial infections and hard-to-treat viral infections. We have proudly built a world-class, in-house drug R&D organization in Malvern, PA with over 70 employees.

Our most advanced development-stage product is taniborbactam (formerly VNRX-5133), an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases (MBLs), including ESBL, OXA, KPC, NDM, and VIM enzymes. Venatorx initiated enrollment in its Phase 3 trial of cefepime-taniborbactam in patients with complicated urinary tract infections (cUTIs) in August 2019 and top-line results are expected by the end of 2020. Our second development-stage product in clinical development is VNRX-7145, an orally bioavailable BLI that in a fixed combination with the third generation orally bioavailable cephalosporin, ceftibuten, has the potential to rescue activity of the partner antibiotic against ESBLs and key carbapenem-resistant Enterobacteriaceae, including those expressing KPC and OXA carbapenemases.

Additionally, we have a broad pipeline of preclinical programs including a novel class of Penicillin-Binding Protein (PBP) inhibitors that are impervious to beta-lactamase-driven resistance, and novel antiviral agents targeting Hepatitis B Virus. All Venatorx investigational molecules were discovered internally and our scientists have filed over 100 patents spanning multiple research programs.

Venatorx has received significant funding awards from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH); Wellcome Trust; the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Service (HHS); the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA); and CARB-X, and as well as private equity investments from Versant Ventures, Abingworth and Foresite Capital.

As the CMC Development Manager, you will work closely with the CMC team to develop project plans, track deliverables, and communicate project status to cross-functional project teams. You will be directly responsible for coordinating research and development activities as well as managing manufacturing operations at vendors, including development of requests for proposals (RFPs), negotiation of vendor contracts, and managing vendor deliverables.

Responsibilities include:

    Ensure that project deliverables are on time and within budget while meeting project objectives
    Schedule and manage project meetings, including agendas, minutes, and action items
    Work closely with project teams, maintaining constant communication to ensure timely updates on current project status, issues, contingencies, and milestones
    Work closely with vendors/partners to ensure clear alignment of common strategy, coordination of key activities, clear communication flow, and that decisions are made and resources leveraged to achieve the goals of the partnership
    Maintain, manage, and communicate project plan(s), including status, risks, and mitigation planning to senior management
    Accurately forecast, report, and manage project costs (budget)
    Act as the CMC interface with finance and legal to establish contracts, purchase orders, and manage vendor relationships
    Responsible for the day-to-day oversight of CMC activities at vendors
    Work cross-functionally with internal departments and external resources on process and analytical development, manufacturing and technology-related issues
    Plan vendor meetings, set agendas, and ensure services provided by contract manufacturing organizations (CMOs) are in alignment with the agreed scope, cost and timeline
    Ensure accurate tracking and governance of CMC information and data: stability programs, batch disposition and inventory, retest/expiry-date tracking
    Partner with QA for vendor qualification and vendor audit readiness

Successful candidates will be able to demonstrate:

    Bachelor’s Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related technical field required; Master’s preferred
    5-7+ years of progressively responsible experience in biopharmaceutical-based cGMP manufacturing operations in a pharmaceutical, biotechnology, CMO or related environment OR equivalent experience and/or education.
    Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
    Experience overseeing/managing global CMOs conducting activities including R&D, clinical and commercial manufacturing
    Significant project leadership experience
    Demonstrated ability to motivate and mentor peers and technical staff at CMOs by fostering a culture of continuous improvement and operational excellence.
    Ability to work independently and collaboratively, as required, in a fast-paced, matrix team environment consisting of internal and external team members.
    Must be proficient with spreadsheets, presentation and project-management software
    Significant project leadership experience
    Ability to influence and build good work relationships
    Strong analytical/problem-solving skills and the ability to understand complex issues and adapt to changing priorities and deadlines
    Possess a strong data driven, analytical approach
    Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects/tasks.
    Excellent verbal and written communication and skills including demonstrated technical writing experience. Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner while using tact and diplomacy in interacting with people at all levels in organizations.