Technical Services Senior Manager

Bayer Healthcare LLC•Myerstown, PA

1d•Hybrid

About The Position

Oversee the development and manufacturing of pharmaceutical and nutritional dosage forms. Develop new and marketed products within established timelines. Develop project risk assessment, technical success criteria, target product profile, and contingency plans for development activities. Define critical process parameters, formula development, and scale-up of products. This role requires a Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a closely-related medical field, and 3 years of experience in a pharmaceutical environment. Responsibilities include scaling up pharmaceutical and nutritional products from lab-scale to commercial production using Stage Gate; authoring technical documentation to support launch and regulatory approval of new and/or updated products; establishing product development processes, critical process parameters, and formula developments for identification of design space identification; applying regulatory requirements and industry standards to pharmaceutical and nutritional product development; supporting manufacturing operations of solid pharmaceutical dosage forms, including immediate, extended, and/or modified release, and liquid pharmaceutical dosage forms in a GMP environment; and applying Quality by Design and statistical principles to optimize manufacturing processes that are scalable and transferable to commercial sites in compliance with FDA regulatory requirements. Telecommuting is permitted from a home office location within a reasonable commuting distance of Myerstown, PA, up to one day per week. Up to 20% U.S. and international travel is required.

Requirements

Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics or a closely-related medical field
3 years experience in a pharmaceutical environment scaling up pharmaceutical & nutritional products from lab-scale to commercial production using Stage Gate
Authoring technical documentation to support launch & regulatory approval of new and/or updated products
Establishing product development processes, critical process parameters and formula developments for identification of design space identification
Applying regulatory requirements and industry standards to pharmaceutical and nutritional product development
Supporting manufacturing operations of solid pharmaceutical dosage forms, including immediate, extended, and/or modified release, and liquid pharmaceutical dosage forms in a GMP environment
Applying Quality by Design & statistical principals to optimize manufacturing processes that are scalable and transferable to commercial sites in compliance with FDA regulatory requirements

Responsibilities

Oversee the development and manufacturing of pharmaceutical and nutritional dosage forms.
Develop new and marketed products within established timelines.
Develop project risk assessment, technical success criteria, target product profile, and contingency plans for development activities.
Define critical process parameters, formula development, and scale-up of products.
Scale up pharmaceutical and nutritional products from lab-scale to commercial production using Stage Gate.
Author technical documentation to support launch and regulatory approval of new and/or updated products.
Establish product development processes, critical process parameters, and formula developments for identification of design space identification.
Apply regulatory requirements and industry standards to pharmaceutical and nutritional product development.
Support manufacturing operations of solid pharmaceutical dosage forms, including immediate, extended, and/or modified release, and liquid pharmaceutical dosage forms in a GMP environment.
Apply Quality by Design and statistical principles to optimize manufacturing processes that are scalable and transferable to commercial sites in compliance with FDA regulatory requirements.