Kadmon Corporation

Warrendale , PA

Director of Formulation Science

Kadmon Corporation
Warrendale, PA Full-time
Posted on July 7, 2019
Director of Formulation Science – Warrendale, PA – Resp for innovat’n, dvlp & implement. of drug prod formulat’ns w/primary respons for tech eval of drug substance & approp excipients to achieve desired target prod profile attributes of machine-ability, prod stability & pharmacokinetic effect. Wrk w/signif independence on projts as subj matter expert rep for co both Chemistry Manufac Cntrl (CMC) & as rep of Clinical Ops & Non-clinical Dvlp groups to estab &understand desired formulat’n attributes. Resp for wrkg w/external parties such as contract manufacs & dvlp orgs to achieve formulat’n objtives. Rep CMC in projt team discussions involv’g drug prod attributes & rel tech topics. PhD in Pharmaceutical Sci or rel + Bachelor’s in Biochem req. 4 yrs exp. as Dir. Formulat’n Sci or in Formulat’n Sci as a Rsrchr in a formulat’n lab req. 4yrs exp to incl formulat’n sci exp as a rsrchr in formulat’n lab; hands-on exp in drug prod formulat’n for variety of investigational medicines incl. small molecules & biologics; 4yrs exp to incl formulat’n dvlp process incl manuf optimizat’n for small molecule & biologics; 4yrs exp w/manufac process, industrial equip & techniques applied to pharma dosage forms (E.G .hot Melt Extrus’ns. Solid Dispersions, Solid Blend’g & Liquid Mix’g Techs. Sterile Operat’n, Compress’n & More); 4yrs exp w/industrial equip & techns applied for manufac or pharma drug prods such as solid dosage forms & familiarity w/sterile lg. molecule preps; 4yrs exp in analytical method dvlp &equip (HPLC, UV, Solid State Characterizat’n, Elisa, Protein Isolat’n & Separat’n), pre-formulat’n studies, dissolut’n methods, microscopy, thermal analysis, & general physicochem characterizat’ns of pharma prods; 4 yrs exp wrkg in regulated environ & w/familiarity w/applic of current good manufac practice (GMP) & pharma guidelines (Ex: ICH); 4 yrs exp w/overall drug dvlp process, incl key aspects of non-clinical (Toxicology, PK, ADME Studies) & clinical app of investigational medicines; 4 yrs’ in statistical dsgn of experimnts, DOE (JMP), & QBD; 4 yrs in dsgn experimnts to address relevant scientific questions/ M-IILE maintain’g up-to-date scientific knowl in rsrch area via literature review. Must be able to travel 25-50% of time, mostly short trips in Northeast w/occasional int’l trips. Contact Sheila Taylor at HR@Kadmon.com or Sheila Taylor, c/o Kadmon Corporation, 450 E 29th St, NY, NY 10016.