Principal Senior Scientist
Technical Services/Manufacturing Science Laboratory
The Principal Senior Scientist will provide technical expertise for the design, startup and execution of the TS/MS laboratory.
This role will be that of a technical leader and mentor of other laboratory scientists and integral in defining the laboratory technical agenda.
Key Responsibilities
* Have an in-depth knowledge of the science of biotech manufacturing and associated laboratory models and analytical tests.
* Understand molecule-specific control strategy and basis of specifications and critical quality attributes.
* Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose laboratory models are developed and transferred.
* Expertise in laboratory scale equipment operation and trouble shooting.
* SUPPORTING THE DEVELOPMENT AND MENTORSHIP OF OTHER LABORATORY SCIENTISTS IN ALIGNMENT WITH AREA MANAGEMENT.
* Leading laboratory investigations in support of production operations.
* Support the design and start-up of the laboratory including equipment configuration and purchase, development of the laboratory data management strategy, establishment of laboratory protocols.
* Support a laboratory startup plan in alignment with the health, safety and environmental team to ensure safe startup and operation.
* Create and review documents including laboratory SOPs, material specifications, protocols, and work instructions.
* Establish partnerships to enable cross functional work with the quality control laboratory and other sites to ensure facility startup objectives are met.
* Understand basic statistical methodologies and statistically based experimental design.
* Identify process improvements and participate in implementation of Lean manufacturing initiatives.
* Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.
Education Requirements:
* PhD degree based in biology, chemistry, biochemistry or similar discipline.
* 7-10 years' experience working in pharmaceutical laboratory and GMP manufacturing environments.
Work Environment:
* These are 8-hour day roles.
* Occasional travel is possible.