Technical Services Senior Manager

Bayer•Myerstown, PA

6d•$143,000 - $165,000•Hybrid

About The Position

This role oversees the development and manufacturing of pharmaceutical and nutritional dosage forms. The Technical Services Senior Manager will develop new and marketed products within established timelines, create project risk assessments, define technical success criteria, target product profiles, and contingency plans for development activities. Responsibilities also include defining critical process parameters, and managing formula development and scale-up of products.

Requirements

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