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Process Development Associate, Small Molecule Drug Product Dev. (210C)

Company: ITech Consulting Partners
Location: New Haven
Posted on: June 6, 2021

Job Description:

u003cdivu003eu003cpu003eu003cstrongu003eJob Typeu003c/strongu003e: W-2 Contractu003c/pu003eu003cpu003eu003cstrongu003eDuration:u003c/strongu003e 12 monthsu003c/pu003eu003cpu003eu003cstrongu003eLocation:u003c/strongu003e Onsite in New Haven, CT with some remote work optionu003c/pu003eu003cpu003eUp to 15% travel, with ability to work independently from remote locations.u003c/pu003eu003cpu003eu0026 u003c/pu003eu003cpu003eu003cstrongu003ePosition Summary u003c/strongu003eu003c/pu003eu003cpu003eOur client is seeking an experiencedu0026 u003cspan style= 'color: #ff0000; 'u003eu003cstrongu003eu003cemu003eProcess Developmentu0026 Associate, Small Molecule Drug Product Developmentu003c/emu003eu003c/strongu003e u003c/spanu003ewho will provide laboratory support by using a combination of strong laboratory skills with experience in formulation design, equipment selection, and process scale-up to help expand their solid oral dosage development capabilities in support of an emerging small molecule portfolio.u0026 u003c/pu003eu003cpu003eu0026 u003c/pu003eu003cpu003eu003cstrongu003eEssential Skills and Qualificationsu003c/strongu003eu003c/pu003eu003culu003eu003cliu003eB.S. Pharmaceutical Sciences or Chemical Engineer with minimum 5 years industrial experience in the biopharma industry (or M.S. with minimum 5 years industrial experience).u003c/liu003eu003cliu003eSmall Molecule product development experienceu003c/liu003eu003cliu003eDeep understanding of formulation design, process development, equipment selection and scale-up for solid oral dosage manufacturing processes.u003c/liu003eu003cliu003eExpertise in development and manufacture of amorphous solid dispersions.u003c/liu003eu003cliu003eAbility to remotely manage process design, development, and scale-up activities at third parties.u003c/liu003eu003cliu003eStrong understanding of cGMPs and regulatory guidances.u003c/liu003eu003cliu003eStrong understanding of Quality by Design (QbD) principles of process design.u003c/liu003eu003cliu003eTechnical expert who will remain abreast of the latest scientific and regulatory trends pertaining to solid oral dosage product design and manufacture.u0026 Evaluate emerging technologies with potential to improve cycle time, supply chain robustness, and/or product quality.u003c/liu003eu003c/ulu003eu003cpu003eu0026 u003c/pu003eu003cpu003eu003cstrongu003ePreferred Qualifications u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eExperience in late-phase process development, including process risk assessments, multivariate DOE studies, and assessment of parameter criticality.u003c/liu003eu003cliu003eExperience in development of drug products targeted toward pediatric patient populations.u003c/liu003eu003cliu003eExperience in planning and implementation of post-approval process and formulation changes.u003c/liu003eu003cliu003eExperience in development of modified release drug products.u003c/liu003eu003cliu003eExperience in development of combination drug products.u003c/liu003eu003c/ulu003eu003cpu003evu003c/pu003eu003c/divu003e ', 'location ': 'New Haven, CT ', 'remote ':null, 'jobtype ': 'contract ', 'remoteoption ': 'notspecified ', 'featuredonjobboard ':false, 'ownedbyagency ':true, 'externalid ': 'j-8291

Keywords: ITech Consulting Partners, New Haven , Process Development Associate, Small Molecule Drug Product Dev. (210C), Other , New Haven, Connecticut

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