Dallas Metro Area, TX
Job responsibilities including brief description
(to include key result areas, specific accountabilities, tasks)
PT&D On Market Technical Scientists are responsible for providing expert technical support to Lokelma manufactured internally at the Lokelma site. This job description is relevant for On Market Technical Scientists whose subject matter expertise is derived in inorganic chemistry, analytical sciences, process engineering & material science. These roles will not have direct reports. Responsibilities include:
Is trained in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management & product security.
Provision of technical expertise to aid in the resolution of manufacturing/analytical method/process issues & complaints impacting supply or manufacturability.
Input to the development of suitable corrective and preventive actions in support of investigations.
Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion etc) and business continuity plans through delivery of the drug substance control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
Support a prioritized portfolio of project activities.
Provide technical support during the transfer of established products within the site (eg new manufacturing trains/scales including support for equivalency determination as applicable.
Support complex technical improvements or change activities assuring API performance.
Support for drug substance process validation programs in the support of transfer and change activities.
Management of product knowledge throughout the lifecycle.
Provide support to product, and/or method lifecycle activities to ensure equivalence across sites eg integrated product reviews, specifications, methods, processes.
Provides input for process trending including investigation of out of trends.
Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies to aid in the improvement of manufacturing processes and or methods.
All these activities will have a significant impact on the overall success of Operations as well as ensuring the commercial viability of current products. The activities of the group help to ensure availability of all products to the commercial organization.
Education, Qualifications, Skills and Experience (refer to CV, IDP etc. if applicable)
Have an understanding of the overall drug development and commercialization process from development, launch and through life cycle management
Likely to be educated to BSc/BEng or PhD level in an appropriate discipline.
Have in depth understanding of their discipline, such as, inorganic chemistry, analytical, process engineering or material science.
Have an understanding of principles, applications and management of SHE and cGMP.
Evidence of good communication skills.