MSAT Process Specialist / Expert – Formulation and Filling (m/f/d)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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

·         Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals.

·         Act as TS/MS representative for the Formulation & Filling processes, addressing complex process issues in a structured manner and escalating as appropriate.

·         Act as link between operations, product team and local stakeholders for process related topics.

·         Ensure the preparation, formulation and filling process follow industry and authority expectation and are in full compliance with applicable regulations.

·         Provide technical guidance for formulation and aseptic filling processes to the whole site and serve as a source of knowledge to the operational staff.

·         Support validation and lifecycle management of filling processes, equipment, and control strategies to ensure robust and compliant commercial supply.

·         Own complex process deviations and drive change controls through in-depth understanding of critical process steps and process controls

·         Collaborate cross-functionally to drive continuous improvement and present responsible area during inspections and audits.

·         Ensure processes, procedures, and batch documentation are accurate, executable, and compliant with GMP and regulatory expectations.

Expected Qualifications

·         Degree as engineer, pharmacist, or equivalent qualifying certification/training.

·         At least 5 years of professional experience in the pharmaceutical industry.

·         Knowledge of GMP and operational skills.

·         Good knowledge of document and project management.

·         German language proficiency and basic English knowledge.

Additional Preferences

·         Experience in parenteral manufacturing.

·         Strong analytical and synthesis skills.

·         Excellent interpersonal and communication skills.

·         Ability to work independently and in a team.

·         Ability to coordinate teams without direct hierarchical power.

·         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.

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

€52.500 -  €121.000

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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