CDI – Représentant Produit Process / Scientist – DPEM TSMS – H/F


Job title: CDI – Représentant Produit Process / Scientist – DPEM TSMS – H/F

Company: Eli Lilly

Job description: 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.

Dans le cadre de son développement stratégique, le site d’excellence européen de (proche Strasbourg), recrute un

« CDI – Représentant Produit Process / Scientist – DPEM TSMS – H/F »

Eli Lilly & Company, entreprise de santé de dimension internationale, met tout en œuvre pour découvrir de nouvelles alternatives thérapeutiques et procurer à ceux qui en ont besoin des soins de qualité.
C’est dans cet esprit que nous nous tournons vers l’innovation et développons un portefeuille de médicaments dans des aires thérapeutiques innovantes, visant à améliorer l’espérance et la qualité de vie de millions de patients dans le monde.

Les 1100 collaborateurs de notre site de production de Fegersheim (à proximité immédiate de Strasbourg) sont acteurs de notre ambition et produisent des médicaments injectables contre le diabète, l’ostéoporose, des anticorps monoclonaux (notamment en cancérologie) ainsi que des hormones de croissance. Nos médicaments sont exportés dans plus de 100 pays. Fort de 50 ans d’expérience en production pharmaceutique, le site participe à l’industrialisation des nouveaux produits prometteurs de Lilly.

Présentation de l’organisation :

Lilly France is currently looking for a Product Process TSMS Scientist to be part of Drug Product External Manufacturing (DPEM), a global group whose collaborators are located in different geographies.

Drug Product External Manufacturing is responsible for making medicine at contract manufacturers located globally, selected by Lilly to make drug product that will bear the Lilly brand. DPEM manages technical, quality, supply and financial aspects of all issues with the contract manufacturers (CM) and alliances who supply product to Lilly to ensure risks to Lilly in manufacturing product outside Lilly is appropriate and provides optimum protection to the Lilly brand.

This role is responsible for all technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. This role is the process expert for the step(s) of the product(s) and process(es) for each contract manufacturing relationship. This role is a member of the joint process team and has direct responsibility for oversight of the day to day operations at the CM.

This role is based on Fegersheim site, near Strasbourg (France).

Responsabilités :

Key Objectives/Deliverables :

-Support On-Going CM Operations by providing technical oversight

-Understand the purpose and science of the process and have a thorough understanding of the entire process flow
-Define, understand, and own the operational control strategy; including the key process parameters and critical quality attributes
-Understand product history and potential failures modes for the process and the associate countermeasures
-Generate, review, revise, and maintain as needed all the manufacturing and validation documentation (e.g. master production records and packaging orders, validation plans/protocols/reports, qualification protocols/reports, Process Flow Documents). Ensure those documents meet Lilly Global Quality Standards expectations.
-Maintain awareness of issues & progress their resolution ensuring that senior management are notified through approved escalation procedures
-Ensure planned changes and deviations are managed through the corresponding Lilly computer system.

-Respond in a timely manner and accurately to requests for information.
-Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored to ensure processes are in control, capable and in continuous improvement.
-As required, represent DPEM in appropriate GPLOT (Global Post Launch Optimization Teams).
-Ensure that Quality metrics are on target for the product/process supported: Deviation, Complaints, Quality Plan actions, Quality Backlog etc.

Relationship with CMO

-Make regular communication with and visits to External Manufacturers to ensure current awareness of their operations and to maintain a strong working relationship with External Manufacturers, and the local affiliate if necessary.
-Ensure Technical Agenda and discussion is agreed and executed in timely manner. Maintain technical visit and meeting minutes as required.
-Identify training needs with the External Manufacturer. Arrange and conduct training during site visits if necessary.
-Assist local affiliate with management of their product portfolio as required.
-Support external and internal audits performed at the CM related to Lilly product portfolio.

Product Stewardship

-Monitor critical process parameters, react to special/common cause and proactively generate improvement opportunities.
-Ensure process control and capability. Establish metrics and incorporate them to daily process activity.
-Understanding process and product regulatory commitments
-As required be a source of technical information for other scientists and GLPOT. Active participation in Lilly Global Product Assessment, Site Compliance Report as any other request.
-Resolve technical / quality issues, in conjunction with QA as required.
-Lead Root Cause Analysis investigation and provide process expert knowledge in all deviations and complaints
-Provide technical support on regulatory documents.

Continuous Improvement

-Analyze the process routinely in order to identify vulnerabilities and inefficiencies of the process and promote improvement projects.
-Monitor the status of processes to ensure they are consistent with, corporate standard expectations and the continuous improvement strategy.

Technical Transfer Projects

-Liaise with engineering consultants, equipment suppliers, and others to define facility and equipment needs.
-Provide help and guidance on development of appropriate manufacturing and quality systems, in conjunction with QA.
-Develop and own the Technology Transfer Plan. Define (with the project lead and/or global molecule steward) the appropriate validation strategy according to the Regulatory and Lilly Standard expectation.
-Review External Manufacturer qualification protocols and reports.
-Supervise PQ, validation and manufacturing start up to ensure success.
-Run Process Validation batches and document the results in the Final Validation Report.
-Ensure External Manufacturer is technically competent to run the process and are made aware of any changes in technical requirements.
-Inform properly and in a timely manner to TS/MS Sr. Director about project status, issues, etc. Identifying issues root case and recommended action plans to solve them and avoid recurrences.
-Identifying resources and trainings needed to achieve area targets
-Collaborate with Technical Project Manager to ensure the appropriate technical governance through the business processes.

Department Initiatives

-Maintain regular communication with management and network leaders through effective participation in S&OP meetings, GPLOT and MR reviews
-As a team member, actively participate and contribute to the Joint Process Team objectives.
-Ensure appropriate actions are entered into and tracked through all monitoring systems.
-Provide input in monthly reports and metrics
-Actively pursue opportunities for continuous improvement (both process and procedural)
-Model Safety behaviors
-Effectively instruct/mentor others

Profil recherché / Connaissances requises :

Basic Requirements:

-Master Degree in Pharmacy, Chemistry, Engineering, or similarly related fields
-Minimum of 3 years experience in pharmaceutical manufacturing and/or technical services

-Willingness to travel (up to 30% of your time, mainly EU travels)

-Very good level in English mandatory (read/spoken/written)

Les « petits plus » :

Additional Preferences

-Prior experience supporting parenteral manufacturing, with a preference in vials aseptic filling

-A thorough understanding of cGMPs and drug product manufacturing
-Good communication skills, especially attention to detail in written procedures and protocol development
-High degree of technical curiosity and critical thinking
-High learning agility
-Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment
-Use of data and science to support decisions
-Willingness to learn new technologies
-Capability to work in a virtual and complex environment
-Appreciation for cultural diversity
-Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner and to influence CMs
–Knowledge and ability to apply basic statistical tools
Regulatory related experience
-Equipment, utility, and facility qualification experience

-Established technical, quality, and internal networks

Informations complémentaires :

Additional Information:

Shift is days, but off-hours may be necessary to support operations
Travel is possible, up to 30%
This job is fast paced with changing priorities

Position rattachée à l’entité globale DPEM, et poste basé impérativement sur le site de Fegersheim (15 min du centre de Strasbourg, usine desservie en transports en commun et par des pistes cyclables).

Avantages sociaux : intéressement/participation, mutuelle santé & prévoyance, formule de retraite sur complémentaire, prime transport, salle de fitness, salle de musique, restaurants, conciergerie etc.

Parcours de formation terrain et d’intégration assuré

Plan de carrière : évolutions à 3 ans

Cadre de travail appréciable : société qui investit aussi bien dans les équipements que dans l’humain. Ainsi, vous pourrez participer à des projets stimulants dans un environnement en forte évolution

Retrouvez toutes les informations concernant Lilly France, nos valeurs, et notre culture d’entreprise sur notre et suivez nos actualités sur les réseaux sociaux !

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly

Expected salary:

Location: Illkirch-Graffenstaden, Bas-Rhin

Job date: Tue, 13 Feb 2024 23:07:24 GMT

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