small11

 

CMC Drug Product Lead 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 Drug Product Lead, you will be responsible for the planning and execution of Drug Product CMC development and manufacturing, to support progression of clinical and preclinical candidates. This position will collaborate with Venatorx project team members, external consultants, and contract service providers on drug product development strategy, detailed planning, and execution.

Responsibilities include:

    Manage collaborations with contract service providers on development and manufacturing activities, including but not limited to pre-formulation, excipient selection, formulation prototyping, small scale manufacturing process development, process scale-up, and clinical manufacturing.
    Manage the procurement of raw materials and packaging components to contract service providers to support development and clinical manufacturing.
    Provide technical oversight of development activities at contract service providers. Review and interpret formulation and process development reports authored by contract service providers and ensure technical adequacy to support regulatory filings.
    Perform technical review of contract service provider pre-executed master batch records. Provide on-site coverage of technical batches and clinical batches. Participate in post-manufacturing technical activities, including batch record reviews and manufacturing investigations.
    Identify opportunities to optimize the manufacturing processes, focusing on manufacturing quality, process robustness and efficiency.
    Contribute to the authoring of CTD modules to support regulatory submissions (IND through NDA). Contribute to authoring of responses to questions from regulatory authorities.
    Contribute to the authoring of background packages to facilitate productive discussions with regulatory authorities.
    Develop and maintain a comprehensive understanding of regulatory guidance pertaining to drug product development and commercialization.
    Collaborate with project teams to meet project objectives, budget, and timelines.

Candidates will demonstrate:

    Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely-related disciplines with 5+ years of drug product development experience, or MS with 7+ years of relevant drug product development experience or BS with 10+ years of relevant drug product development experience.
    Ability to apply sound scientific principles in the development of formulations and the processes used to produce them.
    Experience successfully partnering with CDMOs on product development and clinical manufacturing.
    Strong organizational and communication skills.
    Self-starter and a team player that will thrive in an entrepreneurial environment.

Ideal candidates will be able to demonstrate:

    Ph.D. degree in in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or other relevant scientific discipline.
    10+ years of drug product development experience in pharmaceutical/biotech industry.
    Knowledge of drug product CDMO landscape, ability to contribute to the identification and selection of CDMO partners.
    Experience developing parenteral formulations.
    Experience in the development of products containing more than one active ingredient (i.e. fixed dose combinations).
    Experience in late phase development activities, e.g. manufacture of drug product supplies for pivotal clinical trials, registration stability studies, and process validation.
    Experience authoring New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.

 
Equal Employment Opportunity/M/F/disability/protected veteran status