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Job Description

The API Manufacturing Science & Technology (API MST) department provides technical solution to support Small Molecules and Oncology Operating Unit. This is a technical role in a rapidly growing pharmaceutical company where we use an outsourcing model for some of our manufacturing and testing activities. Products supported are primarily complex synthetic molecules.

About the role:

As Sr. Principal Scientist, you will be the primary technical point of contact for the API SMO OpU with external Contract Manufacturing Organizations (CMOs). The primary role will be to provide scientific and technical expertise for all drug substance related activities, ensuring that new and existing drug substance technology and related processes, procedures and specifications are transferred to our CMOs in a manner compliant with all regulatory and quality standards and to support cost-effective technical processes suitable for robust commercial production.

How you will contribute:

•  New product introduction, New Chemical Entity process validation and CPV.
•  Technology selection and acquisition.
•  Process design, development, optimization and verification.
•  Technology transfer.
•  Continuous improvement.
•  Change Management.
•  Technical support and oversight of commercial API manufacturing.
•  Define capabilities required at the CMO to successfully support new product introduction and new chemical entity validation manufacture.
•  Assess gaps in capabilities and implements plan to build required capabilities at CMO to support technology transfer.
•  Partner with Pharmaceutical Sciences (PS) and Global Manufacturing Sciences (GMSci) in late-stage process development with technology selection, process design and optimization.
•  Design, develop and optimize product manufacturing process using robust DoE and QbD principles.
•  Author, review and approve relevant technical documentation, protocols,

reports and regulatory submissions including Process Risk and Safety,

Assessment, Technology Transfer Plan, Validation Master Plan etc.
•  Implement right first time (RFT) Technology Transfers and timing to business needs ensuring quality, costs and regulatory requirements.
•  Contribute and support due diligence activities for new product acquisition.
•  Assure proposed vendors are capable of passing regulatory inspections by the FDA or other government regulatory agencies.  
•  Author and review regulatory documents for technical consistency and compliance for NDA and DMF etc.  Provides responses to technical queries from the agencies.
•  Lead, prioritize and drive investigations to completion, using standardized approaches to timely closure to avoid product supply concerns.  Ensures timeline for tasks are met and facilitates corrective action to maintain and where necessary maneuver timeline back on track.
•  Manages and maintains change controls throughout appropriate product groups
•  Develop and maintain technical product knowledge database and technical documents for assigned products.  Dissects and interprets data from various sources, using the information to create scientific reports
•  Lead external CMO network to create or enhance capabilities to deliver RFT the needed quality and quantity of API.
•  Partner with CMOs to ensure quality of drug substance and drive elimination of customer complaints relating to API.  Leads/participates in the deviation investigations, RCA and CAPA.  
•  Build and maintain a network of robust relationships with regulators, CMOs, CROs and Key Opinion Leaders