Assistant Manager, Formulation Development & Tech Transfer

Assistant Manager, Formulation Development & Tech Transfer, Fairfield, NJ: Assist Ass. Dir. in activtes & prjects rlated to frmulation dvlpment of new prdcts & altrnate source API prducts. Reqs: M/h Master Deg. in Pharma. Mnfcturing, Phrmceutics, Prject Mngmnt or rltd occup. & 2 yrs exp. in Genric MSAT. M/h: Exp. in frmlation dvlpment of solid oral dsage frms (tblets & cpsuls). Ablty to prform tech. trnsfr for ANDA prdcts & site trnsfer prjects. Prficncy opertng mnufctring equip. sch as hi. shear grnlators, fluid bed dryrs, blnders, tblet prsses, cters, encpslation mchnes, & imprntng mchnes. Exp. excutng mnfactring & pckging of exhbt, vldation, & site trnsfr btches. Ablity to tbleshoot cmmrcial mnufcturing issues & spport prduction teams. Exp. prpring qualfction prtcols, prcess vlidation prtocols, & vlidtion rports. Knwldge of FDA reg. & cGMP for slid oral & cntrolld sbstnce prducts. Ablty to prpre reg. doc. for ANDA sub. Knwldge of lbeling lfcycle mngment & incrprting updtes frm RLD or FDA guid. Strng tchncal writing, docmenttion, & comm. skills. Ablty to wrk crss fnctnally w/QA, QC, Prdction, Eng. & RA. Strng org. sklls & attn. to dtail. Dmnstrble accptable sklls in prblm slvng & adhrng to timlnes. 40 hrs p/wk. M-F: 9-5:00pm. M/h prf of lgal auth. to wrk in US. Salary: $131,934 - $133,934 per year. Pls vsit Ingenus Pharmaceuticals' site @ https://www.ingenus.com/careers/  & apply by emailng resume to hr@ingenus.com Ref# 72026.