Scientist TSMS Pharmasuite Full-time

Pharmasuite Role At Lilly Alzey

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities

The PharmaSuite role is responsible for providing technical support for the development, implementation, and execution of a manufacturing execution system (electronic batch record) to achieve reliable, sustainable, and compliant manufacturing of drug products at the Lilly Alzey site. This role will initially focus on the design and delivery of the PharmaSuite production instructions (referred to as tickets), and then transition to support of routine manufacturing operations, including identifying and implementing required PharmaSuite upgrades and ticket changes. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the knowledgeable in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes throughout the product lifecycle, from tech transfer to regulatory submission and beyond to routine manufacturing.

Key Objectives/Deliverables

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Partner with IT, Quality, Production, and Engineering (site based and globally) to develop reliable, sustainable, and compliant manufacturing PharmaSuite tickets.
• Serve as PharmaSuite TS/MS subject matter expert (SME) and provide technical leadership to the PharmaSuite team, specific to process and ticket requirements for drug product manufacturing.
• Translate product control strategy and process flow document (PFD) requirements into accurate instruction sets (e.g. PharmaSuite tickets, electronic batch records, electronic procedures).
• Partner with IT PharmaSuite and other TS/MS scientist resources for ticket design and development inputs, including how PharmaSuite interfaces with other automation systems, LIMS systems, etc.
• Lead/support development of new PharmaSuite tickets; maintain accuracy of PharmaSuite tickets and ensure that they can be executed as written.
• Participate in design reviews, final design specification review, and localization of PharmaSuite tickets.
• Provide technical support for all start-up activities (e.g., tech transfer, process validation).
• Identify changes required for PharmaSuite, solicit input from stakeholders, and ensure changes are implemented consistently with operational practices.
• Lead the change prioritization process, working with the business to understand change requirements and collaborating with IT to understand complexity.
• Power user for PharmaSuite upgrades in order to write/approve test scripts accordingly.
• Lead training and troubleshooting for Operations.
• Provide technical support for non-routine investigations (e.g., deviations, complaints).
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents specific to PharmaSuite, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Serve as technical interface external to the Alzey site.
• Provide audit support, as needed.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Basic Qualifications

• BS or MS in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, Biochemical Engineering, or other related scientific discipline
• Knowledge and understanding of parenteral drug product manufacturing, including equipment, facilities, computer systems and operations
• Experience supporting cGMP manufacturing (specifically within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.)
• Ability to learn new processes and computer system applications
• Strong computer skills
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.