Genus Lifesciences™ is a specialty pharmaceutical company
engaged in the development and commercialization of generic and
branded pharmaceutical products. Founded in 1999, Genus
Lifesciences™ employs over one hundred fifty professionals in all
phases of pharmaceutical operations, and its products are available
in pharmacies and other retail outlets throughout the United States.
In addition to its local presence, Genus Lifesciences™ has on-going
research efforts through global partnerships related to its
Manager Product Development
Department: Product Development
Reports to: Director, Product Development
Responsible for development of solid and liquid oral dosage
forms and topical dosage forms.
Prepare the development plan for proposed projects and manage
cross functional teams.
Set up Quality Target Product Profile (QTPP) and
determine/optimize critical material attributes (CMA) and critical
process parameters (CPP) to achieve critical quality critical
quality attributes (CQA).
Resolve complex commercial manufacturing issues being mindful
of Supply, Quality, and Regulatory constraints.
Support continuous process improvement activities, as needed.
Author relevant CMC sections of regulatory documents.
Prepare and oversee project data trending activities and
preparation of management review presentations.
Provide insights related to regulatory and business impacts in
order to define and implement effective strategies for different projects.
Prepare and review product development reports, protocols and
batch records under quality guidance issued by FDA.
Manage clinical and bioequivalence studies at different CROs.
Provide input on the sourcing of equipment and materials for
product development needs.
Provide technical and project leadership while being an
individual contributor in consistent, creative and innovative manner.
Execute scientific experiments to develop robust formulation