Senior/Principal Scientist Tech Transfer

Eli Lilly and Company; Alzey; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Zusammenfassung

Eli Lilly and Company in Germany is building a high-tech parenteral manufacturing site in Alzey. The role is part of the TS/MS team, leading tech transfer and ensuring product lifecycle management for new lines. You will coordinate deviations and support technical projects to improve process control and productivity.

Ideal candidates hold a BS or MS in a related science, have GMP experience in parenteral manufacturing, and are fluent in English. German language skills are a plus.

Qualifikationen

• Knowledge of GMP in parenteral manufacturing.
• Experience in Tech Transfer planning and execution.
• Strong knowledge of risk management as part of validation strategy.
• Strong technical writing and presentation skills.
• Fluent in English.

Aufgaben

• Act as tech transfer lead to own, plan and execute tech transfer for products on a new aseptic filling line.
• Coordinate deviations related to tech transfer and complex deviations with product impact.
• Be point of contact for product-related questions for all site stakeholders.
• Manage product lifecycle after start of routine manufacturing.
• Prepare, review and approve technical documents and change controls, regulatory submissions, and reports.
• Support and/or lead technical projects to improve process control, yield and productivity.
• Provide product-related counseling to operations during routine manufacturing.
• Present tech transfer and product topics during internal and external inspections.

Kenntnisse

Tech Transfer

Risk management

Technical writing

Presentation skills

English fluency

Ausbildung

BS/MS in Microbiology/Biology/Biochemistry/Engineering

Jobbeschreibung

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.

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of “Excellence,” “Integrity,” and “Respect for People.”

In this role you will be part of the TS/MS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TS/MS team is the technical owner of the process — from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly’s global technical network.

Key Objectives/Deliverables:

• Act as tech transfer lead to own, plan and execute the tech transfer for products on a new aseptic filling line. Represent the sending site as part of the tech transfer.
• Own and coordinate deviations related to the tech transfer and complex deviations with product impact.
• Maintain a deep understanding of product related process aspects and act as point of contact for product related questions for all stakeholders on site (e.g. quality, operations, engineering).
• Management of product lifecycle after start of routine manufacturing.
• Prepare, review and approve technical documents, as required, such as gap assessment, tech transfer plan, development studies and related protocols and reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, and APRs.
• Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield and productivity.
• Provide product related counseling to operations during routine manufacturing.
• Present the tech transfer and product related topics during internal and external inspection.

Expected Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• Knowledge of GMP and experience in parenteral manufacturing.Experience in Tech Transfer planning and execution.
• Strong knowledge of risk management and understanding / ability to use risk assessment tools as part of a validation strategy.
• Strong technical writing and presentation skills.
• Fluent in English.

Additional Preferences:

• Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
• Able to communicate in German.

What to consider:

• Role is Monday through Friday site-based (Alzey) with the ability to travel to Indianapolis and other global Lilly sites as required.
• Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes 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.

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