Description

Sr Project Manager, Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, timing + roles + responsibilities for prgms incl scale-up activities, process validation, post-validation changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other depts by leading proj w/ organizing interexperiment teams + driving timelines. Collab w/ Supply Chain to ensure inventory current + sustainable for dev + launch. Follow-up w/ teams to update plan + prioritize activities for successful proj implementation. Lead cross-funct meetings to ensure funct deliverables understood + timelines on track. Manage day-to-day activities of proj team. ID + resolve issues that present risk to on-time implementation of program/proj. Help dev + maintain ongoing proj expenses + annual bdgt. Prep weekly/monthly update docs, proposals, + presentations to sr leadership. May undergo drug screening.

Requirements

Must have Bach in Chem, Pharm Sci, or rel sci field, 5 yrs rel exp working in GMP production, supply chain or technical services within pharmaceutical industry, and required skills (5 yrs exp). In the alternate, must have Master's in Chem, Pharm Sci, or rel sci field, 4 yrs rel experience working in GMP production, supply chain or technical services within pharmaceutical industry, and required skills (4 yrs exp). Required skills include: working with solid and liquid dosage forms in pharmaceutical setting; following cGMPs and FDA guidelines; writing protocols and reports, including SOPs, investigations, root-cause analyses; Microsoft Office; JDE (inventory management) and MC (documentation/QMS/eBR); and vendor management.