Gerry Enos Email & Phone Number

Remote

Greenville, Nc

Boston, Ma

Responsible for developing container-closure systems for new Oral Solid Dosage forms:* Select primary package components for all compounds in late stage development.* Utilize predictive models to estimate shelf life and confirm appropriate primary packaging.* Coordinate package tests (MVTR studies, shipping studies, child-resistant/senior-friendly).* Author CMC sections (S.6, P.2.4, P.7) for regulatory submissions & responding to queries.* Manage timely completion of Change Controls, Investigations, and CAPAs for packaging.* Provide technical support for Launch Readiness at CMO packaging partners in US and EU.* Co-Lead the introduction of MAC S-100 blister machine for developmental stability packaging.

Suffern, Ny

Accountable for Oral Solid Dose product launches & daily commercial packaging operations:* Prepare registration packaging & launch activities (i.e. change control initiation, BOMs and master batch records, new printed components, new tooling, and line qualifications).* Review & approve primary/secondary packaging specs, artwork, and die lines.* Work with preferred vendors to develop & qualify new components & tooling (change parts).

Groton, Ct

* Support the primary package development & selection for all Solid Oral Dosage forms.* Screen & select primary packaging components for new drug products.* Coordinate ICH packaging activities between project teams & sites.* Assemble required packaging information for CMC section of NDA / MAA regulatory filings.* Support clinical packaging needs from Phase I through NDA approval.

Ann Arbor, Mi

Ann Arbor, Mi

Ann Arbor, Mi

Morris Plains, Nj

Morris Plains, Nj

Morris Plains, Nj

Vega Baja, Pr

Bachelor Of Science, Packaging With Honor

Activities and Societies: Pi Kappa Gamma - Packaging Fraternity

Associate, Liberal Arts