The ASTL is responsible for the leadership and delivery of business-critical projects to support all analytical aspects related to the late phase of the product lifecycle for key GSK products, including managing comparability studies and characterization strategies for post-approval changes.
Locations (2)
Ware, Hertfordshire, United Kingdom
Upper Merion, Pennsylvania, United States
Responsibilities
Provide technical analytical leadership for programs, projects, and activities related to the specific product/s under the ASTL accountability to ensure business priorities and targets are met (NPI, product transfers, change management, regulatory submissions).
Be accountable for the Analytical Product strategy (APS); maintenance and update of the APS through the post-approval product lifecycle, recommending specification and stability strategies, and novel analytical technologies.
Manage and define comparability studies and suitable characterization strategies to support post-approval changes.
Compile and recommend acceptance criteria for release and stability tests to feed into comparability strategies around TT process, change scale, and material change.
Scientist/Engineer, Biologics Technical Operations - Lilly Medicine Foundry
The Foundry Manufacturing Scientist/Engineer – Technical Operations supports and potentially executes on shift operations activities to ensure effective and consistent execution on the operation floor. This role provides on floor operation execution working directly with operators, supports batch readiness and release, and works cross-functionally to provide technical and operational oversight to routine operations.
Compensation
The anticipated wage for this position is $67,500 - $151,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Responsibilities
Provide on the floor shift support for the operations staff for technical, training, and process support and at times execute production activities.
Leverage problem solving skills to evaluate process & protocols, deviations real-time and provide assessments to cross functional process teams.
Apply independent judgement and discretion to execute equipment commissioning and qualification testing under the guidance of the C&Q.
Conduct and appropriately document production via adherence to digital manufacturing batch records and affiliated SOPs.
Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
Requirements
Bachelor’s Degree in science, engineering or technical field
Associate's Degree in science, engineering or technical field
HS Diploma/GED
Nice to have: Pharmaceutical Product Research and Development
Nice to have: technical and/or coordination support toward cleaning, changeover, and/or maintenance activities in a GMP production environment
Provide analytical input and expertise into comparability protocols and reports, taking into account non-routine physical properties data and recommendations from Materials Science.
