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AGC Bioogics - Stage Supply Chain

 Data di pubblicazione: 25/11/2022

 

 

Agc Biologics, azienda leader nel Cell & Gene Therapy sta ricercando uno stagista da formare in ambito Supply Chain Planning.

Scopo Del Progetto Formativo

Lo stagista verrebbe inserito nel team Supply Chain e verrebbe affiancato dal Planning Supervisor al fine di apprendere i principi della pianificazione degli approvvigionamenti all’interno di un’azienda di biotecnologie. Imparerà a monitorare le scorte di magazzino per evitare stock out oppure over stock utilizzando il gestionale Dynamics AX di Microsoft. Avrà modo di interfacciarsi con le diverse funzionali aziendali sviluppando le skill relazionali e di lavorare in team.

Attività Principali Del Progetto Formativo

  • Pianificare in modo efficace e secondo criteri GMP gli approvvigionamenti dei materiali attraverso elaborazione dei fabbisogni e conseguente emissione di RDA;
  • Monitorare e ottimizzare lo stock dei magazzini di sede e nel magazzino esterno, interfacciandosi con Magazzino per i trasferimenti intercompany;
  • Monitorare il fabbisogno materiali evidenziato dalle varie unità al fine di evitare stock out oppure over stock;
  • Ottimizzare l’approvvigionamento dei materiali, interfacciandosi con Ufficio Acquisti;
  • Interfacciarsi con le diverse funzioni aziendali per analisi sui materiali;
  • Supporto a Produzione per uso di BOM tramite MRP
  • Problem solving delle tematiche collegate al gestionale MS_AX ;

Candidato Ideale

  • Laurea Triennale o magistrale in ambito Ingegneristico e/o Economico;
  • Ottima conoscenze informatiche (Office, in particolare Excel);
  • Buona conoscenza inglese;
  • Persona schematica, puntuale, precisa e volenterosa di inserirsi all’interno di un team dinamico.

I dati inviati saranno trattati da AGC Biologics S.p.A., in qualità di titolare del trattamento, sulla base del consenso espresso dal candidato per un periodo massimo di 6 mesi, salvo diversa autorizzazione del candidato stesso.

 

È possibile inviare la propria candidatura a questo link.

EryDel - Global Clinical Study Manager

 Data di pubblicazione: 15/11/2022

 

 

EryDel SpA is a global late-stage biotech company aimed at developing and commercializing therapies for the treatment of rare diseases delivered by its proprietary red blood cell technology.  Its most advanced product, EryDex, has successfully completed a Phase 3 pivotal study for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established therapy is currently available.

 

We are seeking an experienced clinical professional to help us contributing to the successful implementation and monitoring of clinical studies to ensure our studies are conducted in accordance to ICH GCP and applicable regulations.

 

Essential duties and responsibilities

  • Maintain oversight of the trial, driving issue identification and resolution, contingency planning, and decision-making.
  • Contract Research Organization (CRO) management, with specific focus on the oversight of all deliverables outsourced to the CRO.
  • Oversight of external vendors, including contracts and budgets (in collaboration with Budget and Planning responsible): updates for scope changes, review and approval of Vendor contracts, change orders and ensure services are delivered.
  • Establish and maintain strong relationships with the Investigators and site staff, which includes attendance to face to face meetings and Sponsor accompanied visit.
  • Review of regulatory and ethics committee submissions.
  • Manage and approve study and site contracts/budgets.
  • Identify risks and ensure mitigation and contingencies are being initiated and followed through (including management of Corrective and Preventive Action Plans).
  • Build and update study-specific documents, such as Informed Consent Form, IMP related documentation, feasibility related documents, etc..
  • Preparing for Health Authority inspections and QA audits.
  • Maintenance of Sponsor documentation and supervision of Studies’ TMF.
  • Collaborate with all trial team members in setting and meeting the activities and project timelines, in alignment with corporate goals.

 

Qualification & experience

 

  • A minimum of a Bachelor’s or equivalent University degree is required, in a scientific discipline (Biology, Pharmacy, Biochemistry, Medicine)
  • 5-6 years experience as clinical study manager or similar role within the Pharmaceutical industry or Contract Research Organization (CRO)
  • Knowledge of the fundamentals of Clinical Development and experience in project and clinical management
  • Ability to manage all aspects of execution of a clinical trial is required
  • Strong monitoring background
  • Strong knowledge of ICH GCP (valid certificate of training is required).
  • Good working knowledge of Microsoft Office
  • Knowledge and experience with electronic tools used in clinical research such as eCRF, IWRS, eTMF
  • Understanding of basic statistics
  • Experience with clinical supply management
  • Experience in Medical devices is a plus
  • Experience with orphan disease and/or neurology would be an asset

Soft skills

  • Flexible, mature, self-motivated, independent and able to work under pressure while supporting the “Culture of the possible”.
  • Organized, rapid and with special attention to details.
  • Open-minded working well in a remote team environment as well as with external contacts and networks (investigators, consultants and professional service providers) also embracing a multicultural environment.
  • Good leadership skills “Leading by example” including open and clear communication and presentation skills.
  • This position will require up to 30% domestic and international (EU and extra EU) travel.

 

You can apply for this position by sending your CV to emanuela.germi@erydel.com, HR Coordinator.

DiaSorin - Molecular R&D Validation Associate

 Data di pubblicazione: 20/09/2022

 

YOUR MISSION

The Molecular R&D Validation Associate is responsible for conducting laboratory experimentations and investigations in compliance with Quality and Health&Safety procedures with the purpose of drafting a final report. He/she will follow all applicable regulations including, but not limited to, FDA, ISO, IVDD, and CMD/CAS requirements.

 

YOUR CONTRIBUTIONS

  • Assisting in drafting protocols and executing laboratory research activities, in accordance with the company’s quality policies and procedures;
  • If necessary, suggesting new validation procedures while always respecting validation protocols objectives;
  • Once the protocol is approved, he/she will validate the test by conducting laboratory activities;
  • Analyzing the data based on performed tests and interpreting the results, interacting with internal and external scientists;
  • Supporting deviations management;
  • Defining a drafted report to be reviewed by scientists/managers;
  • Performing other laboratory activities when necessary;

YOU

Education: Master’s degree in a scientific discipline

Specialization: Biology, biotechnology

Experience: 1 year experience in a R&D molecular diagnostics laboratory.

Technical Competencies:

  • Basic knowledge of statistics (standard deviation and CV percentage);
  • Ability to work in compliance with the standard GMP procedures;
  • Basic knowledge on nucleic acid extraction;
  • PCR, RT-PCR and Real-Time PCR preferred;
  • Ability to exercise judgment within defined procedures to determine appropriate action;
  • Technical writing skills required;
  • Basic understanding of systems data management;

Skills:

  • Accuracy;
  • Analysis and problem solving capability;
  • Team work;
  • Time management;
  • Good communication skills;
  • Ability to work following rules and procedures

Languages: Basic knowledge of English language is required to read, draft and edit protocols, reports and working instructions.

 

Job Location: Gerenzano (VA) until January 2023. Bresso permanent location.

 

You can apply fot his position by visiting this link

 

Axxam - 

High Throughput Screening IT Full Stack Developer

 Data di pubblicazione: 20/09/2022

 

IThe candidate will join a consolidated team of scientists with top level experience in assay development, High Throughput Screening (HTS), compound management, and lab automation as well as IT experts who have developed and implemented a set of tools, database systems, and data analysis methodologies.

 

The candidate will join the Data Analysis/Compound Management unit and will be dedicated to supporting different IT requests from HTS scientists, working to enable more efficient workflows within our screening platform. Good communication skills are critical, for both collaboration with the scientists of the team as well as for interactions and discussions with our international clients.

 

Beside a broad range of knowledge and skills as detailed below, the ideal candidate will have a background in biochemical information technologies/sciences.

 

The successful candidate must have a high level of self-motivation, attention to detail, sense of responsibility, independence, and the ability to thrive in a goal and team-oriented setting.

 

Major responsibilities:

  • Development and maintenance of software applications and databases for the automation of the entire process of High Throughput Screening, with specific focus on the installation, maintenance, development and implementation of Axxam’s corporate database and specific analysis software dedicated to HTS data analysis and MedChem
  • Full Stack development activities concerning our HTS server, database and user web interface
  • Evaluation and eventual implementation of commercial software for platform improvements
  • Evaluation of new specific IT requests enabling Hit Tailoring Solutions scientists’ workflows
  • Maintaining contact with application specialists and technicians of all software houses used in HTS unit
  • Support and consultancy to company IT Managers for general requests regarding Axxam IT infrastructures.

 

Required qualifications and experience:

  • Master’s degree in a relevant field such as Information Technologies, Engineering, Computer Sciences or equivalent experience
  • Excellent knowledge of operative system Linux
  • Excellent knowledge of at least some of the following programming languages: PHP, Javascript, Jnode, Jquery
  • Knowledge of SQL language and relational database management (Oracle preferred)
  • Knowledge of object-oriented programming, some experience with Java would be a plus
  • Knowledge of web-app development frameworks would be welcome
  • Advanced level in the use of Microsoft Excel, Word and Power Point as user are a plus
  • Strong communication skills, fast learner
  • Fluent English (spoken and written). Knowledge of Italian is a benefit.

 

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.If your background and personal experience fit this profile, please send your complete application, including a brief description of your experience, a letter of motivation, your CV and a list of references to the address below or upload it at our on-line contact centre: http://www.axxam.com/careers/send resume. Please, add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003".

 

You can apply for this position by visiting this link

 

Info Studi - Sviluppatore Dot Net

 Data di pubblicazione: 08/09/2022

 

Info Studi ricerca sviluppatore in ambiente Microsoft .NET.

 

Il ruolo prevede attività di:

  • Sviluppo in team di lavoro
  • Assistenza ai clienti

 

Si richiede:

  • Diploma o laurea in informatica
  • Buona conoscenza della lingua inglese
  • Attitudine al lavoro di gruppo
  • Esperienza di almeno 3 anni su .NET Framework, Xamarin, SQL Server

 

Le candidature possono essere inviate tramite questo link.

 

Axxam - 

Scientist / Cell Biology

 Data di pubblicazione: 08/09/2022

 

Axxam is seeking a talented Scientist to strengthen our activities in the taste and olfactory receptor research. You will participate in the generation, improvement, and functional application of cell-based assays for chemosensory receptors.

You are highly motivated and fully committed with a strong profile in Cell Biology and will perform in vitro cell-based signalling studies to characterize different molecular targets.

Requirements:

  • Significant hands-on experience in mammalian cell culture
  • Transient gene expression in mammalian cells
  • Use of reporter genes (luciferases) in mammalian cell lines
  • Use of luminescence – fluorescence readers (e.g. FLIPR® technology)
  • Knowledge of data analysis software such as Microsoft Excel and GraphPad Prism
  • Strong problem-solving attitude and time management skills
  • Pharma or biotech industry experience is highly desirable.
     

Education:

A Ph.D. in Cell Biology/ Molecular Genetics/ Pharmacology is ideal.

The following skills would be advantageous:

  • Ability to follow instructions closely with a critical alertness
  • Spirit for working in autonomy
  • Knowledge of Bioinformatics
  • Good team player
  • Habit to work with tight deadlines.
     

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.If your background and personal experience fit this profile, please send your complete application, including a brief description of your experience, a letter of motivation, your CV and a list of references to the address below or upload it at our on-line contact centre:

 

http://www.axxam.com/careers/send resume. Please, add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003".

 

You can submit your application by visiting this link.
 

 

AGC Biologics - GMP Downstream Technician

 Data di pubblicazione: 18/05/2022

 

AGCBiologics, azienda leader nel Cell&Gene therapy, sta ricercando un GMP downstream technician.

Attività Principali

  • Purificazione di vettori virali con sistemi cromatografici e di ultrafiltrazione tangenziale seguendo le procedure operative standard e compilando la documentazione GMP, Batch record e moduli;
  • Allestimento delle attrezzature e dei materiali necessari alla lavorazione (preparazione kit disposable, impaccamento di colonne cromatografiche);
  • Preparazione in area GMP di soluzioni da impiegare nei processi di purificazione;
  • Esecuzione di piccoli interventi di manutenzione ordinaria e calibrazione periodica delle apparecchiature;
  • Lavorazioni sotto cappa a flusso laminare: prelievo di campionamenti, trasferimenti di fluidi, filtrazioni di soluzioni e bulk da purificare o purificati;
  • Redazione della documentazione correlata alle attività GMP Manufacturing: Batch Record, SOPs, protocolli e report;
  • Gestione della documentazione relativa a change e deviazioni.

Requisiti

  • Laurea in Biotecnologie o similari
  • Esperienza pregressa nelle tecniche sopraelencate
  • Preferibile esperienza in area controllata (Cleanroom) e familiarità con le GMP

I dati inviati saranno trattati da AGC Biologics S.p.A., in qualità di titolare del trattamento, sulla base del consenso espresso dal candidato per un periodo massimo di 6 mesi, salvo diversa autorizzazione del candidato stesso.

 

You can apply for this position by visiting this link.

 

Axxam - 

HTS Scientist

 Data di pubblicazione: 18/05/2022

 

Axxam is seeking an enthusiastic, organized, and creative cell-biologist for our High Throughput Screening Group. The ideal candidate will be a motivated and expert scientist who can support miniaturization and adaption of cell-based assays for HTS, HTS routine activities as well as mechanism of action studies to enable SAR development.

Experience with HTS, fluorescence- and luminescent-based assays, liquid handling automation are desirable. This position will work as part of a team, following detailed laboratory protocols and analyzing data, to deliver high quality, timely data to customers.

Major responsibilities

  • adaption of cell-based assays to HTS automated station
  • run high throughput screening and compound profiling projects utilizing state-of-the-art automated screening stations in 384 formats with general instruction, good consistency, and strong attention to detail
  • perform data analysis and create reports using established software tools and systems
  • identify potential problems that may affect quality, accuracy, and usefulness of data in screening assays and provide ideas for solutions
  • evaluate, analyse and interpret research data
  • present data to clients
  • write reports for clients
  • respond to changing priorities and handle multiple projects with overlapping deadlines. Demonstrate a strong sense of urgency to deliver quality results to customers by defined deadlines
  • ensure support to colleagues for collaborative projects, and reliability, accuracy, robustness and high quality for data and reports
  • ability to quickly learn and adapt to new processes.
     

Required knowledge and skills

  • relevant experience in assay design, in assay execution and possibly in screening, preferably in industry and/or service-oriented organisation
  • experience in using liquid handling and automated screening stations is a very preferable skill
  • relevant experience and strong working knowledge of in vitro detection technologies
  • experience in leading client projects. Analyse, summarize and interpret data and provide written and verbal updates to clients in timely manner
  • proficiency in Microsoft Word, Excel and PowerPoint. Knowledge of GraphPad Prism and other data analysis software are a plus
  • a self-motivated individual that can function both independently as well as part of a team
  • ability to work effectively under strict deadlines within a team framework in cross-functional projects as well as independent scientist
  • ensure support to colleagues for collaborative projects, and reliability, accuracy, robustness and high quality for data and reports
  • effective communications with colleagues at all levels and with external international partners
  • adherence to protocols and to corporate policies on Quality and Health & Safety
  • fluency in English, written and spoken
  • PhD in Biotechnology / Cell biology or other related discipline is welcome.


Axxam offers a stimulating work environment and a competitive salary.If your background and personal experience fit this profile, please send your complete application, including cover letter including a brief description of your experience, your CV and a list of references to the address below or upload it at its on-line contact centre: http://www.axxam.com/careers/job-listing.

 

Please, include in the message subject “Ref. Junior Legal Specialist_03/2022” and add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003". Axxam S.p.A. is compliant to the provisions of Legislative Decree n. 231/2001.


 

 

AGC Biologics - Quality Assurance Manager

 Data di pubblicazione: 29/03/2022

 

AGC Biologics, azienda leader nella Cell & Gene Therapy, sta ricercando un Quality Assurance Manager.

 

Attività principali:

  • Coordinare le attività dell’unità QA gestendo le risorse ad essa assegnate.
  • Definire con la Direzione gli obiettivi e i KPI di area.
  • Collaborare con il Site Quality Head per la gestione degli investimenti e preparare i budget di competenza.
  • Aggiornare con meeting periodici il Site Quality Head su tutti gli aspetti di Quality e Risk Management.
  • Garantire che tutte le attività di manufacturing e testing vengano eseguite in accordo ai requisiti regolatori (cGMP) e al QMS aziendale.
  • Assicurare l’applicazione del processo di Quality Risk Management.
  • Gestire il processo di BRR e rilascio dei lotti, definendone i flussi e le responsabilità.
  • Approvare la documentazione che attesti la conformità del lotto prodotto ai requisiti GMP e informare la Direzione in caso di problematiche relative al rilascio.
  • Supervisionare il processo di qualifica di materiali e fornitori definendone i flussi e le responsabilità
  • Eseguire le Quality Review per le aree di competenza
  • Fornire supporto a QS nella gestione di CAPA, change, nelle ispezioni sia interne (self inspection) che regolatorie e nella gestione degli audit con i clienti
  • Redigere i Quality Agreement con i clienti
  • Supervisionare le attività di CMC Regulatory Affairs nella stesura/ revisione dei dossier regolatori per la parte di competenza.

 

Requisiti:

  • Laurea in Biotecnologie/CTF o similari
  • Esperienza nello stesso ruolo in azienda farmaceutica di almeno 5 anni
  • Ottima conoscenza della lingua Inglese

 

I dati inviati saranno trattati da AGC Biologics S.p.A., in qualità di titolare del trattamento, sulla base del consenso espresso dal candidato per un periodo massimo di 6 mesi, salvo diversa autorizzazione del candidato stesso.

 

You can apply for this position by visiting this link.

 

Axxam - 

Junior Legal Specialist

 Data di pubblicazione: 29/03/2022

 

Axxam is opening a position for a Junior Legal Specialist, to join its Corporate and Legal Affairs Department. She/he will assist in the legal activities related to the business operations of Axxam and its participated companies as well as in the incorporation process of the new legal entities, to be performed autonomously or in close collaboration with external law firms.

Core job responsibilities:

  • Advise, draft, review and revise commercial contracts (in Italian and English) with domestic and international counterparties, including without limitation CDA, MTA and MSA and provide support in their negotiation.
  • Support in drafting and negotiating of acts, legal letters, term sheets, letters of intent, memorandum of understanding and other relevant documents, as necessary.
  • Advice on compliance, intellectual property and any commercial matter providing the most appropriate legal action(s) to be taken.
  • Support in revising and managing IP related agreements included but not limited to in-licenses, out-licenses and assignment agreements.
  • Support in the legal aspects of M&A processes and any other extraordinary operations, fundraising efforts (also involving the negotiation of investment agreements with potential investors) and other strategic projects.
  • Advise on and provide an interpretation of the main clauses of Grant Agreements, Consortium Agreements and any other collaborative agreement.
  • Fulfillment of any legal and administrative formality (including editing and archiving tasks) linked to the negotiation and the execution of contracts.
  • Perform legal due diligence activities where appropriate and when required.
  • Proactively act as legal business resource to various departments (such as Business Development, Grant Office, Discovery Services and Discovery Research) in the effective identification and management of the main legal risks; build strong and supportive relationships across the organization.
  • Support other members of the legal team and work with external counsels as needed.

Required knowledge and skills:

  • Degree in Law.
  • Essential industrial or law firm experience ideally in law of contracts and/or international business law (at least 1-2 years).
  • Experience in Corporate law is considered a plus.
  • Client oriented with strong interpersonal and organizational skill.
  • Ability to work effectively under strict deadlines within a team framework in cross-functional projects as well as independently, in compliance with contracted timelines and costs.
  • Excellent command of written and spoken English.
  • Proficiency in standard Office software.
  • Effective communication with colleagues at all levels and with external partners in face-to-face meeting and teleconferences.
  • Adherence to internal protocols and corporate policies and guidelines.

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.If your background and personal experience fit this profile, please send your complete application, including cover letter including a brief description of your experience, your CV and a list of references to the address below or upload it at its on-line contact centre: http://www.axxam.com/careers/job-listing.

 

Please, include in the message subject “Ref. Junior Legal Specialist_03/2022” and add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003". Axxam S.p.A. is compliant to the provisions of Legislative Decree n. 231/2001.


 

 

Axxam - 

Cell Biology Technician

 Data di pubblicazione: 29/03/2022

 

Axxam is currently seeking a Cell Biology Technician, for its cell factory Unit, with a strong background in cell biology techniques such as cell bankingcell culturing (including large scale)transfections, and an excellent experience in managing immortalized and primary cell lines. Moreover, Axxam is seeking someone with the following characteristics:

  • Strong commitment to accomplish the duties required by the day-by-day work.
  • Excellent capacity to manage her/his time.
  • Strong problem-solving attitude.
  • Strong capacity to perform team-work activities, dealing with internal clients in pro-active attitude.
  • Flexibility in terms of work hours and peak activities.

She/he will join a team responsible for the management of all the AXXAM’s cell lines required for the high throughput screenings, compound profiling and many other cell-based activities. The position is thus focused 100% on cell lines management and cell provision to internal clients.

She/he will be expected to strictly adhere to company SOPs when performing lab functions, maintaining paperwork and batch records.

The following skills would be advantageous:

  • Good team player.
  • Ability to work with tight deadlines with a sense of urgency.
  • Ability to follow instruction closely, but also to work independently when required.
  • Practice with automated liquid handling systems.
  • Attitude towards automated processes.

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.If your background and personal experience fit this profile, please send your complete application, including cover letter including a brief description of your experience, your CV and a list of references to the address below or upload it at its on-line contact centre: http://www.axxam.com/careers/job-listing.

 

Zcube - Program & Community Specialist

 Data di pubblicazione: 16/03/2022

 

Zambon in recent years has expanded to include diverse, synergetic, businesses related to Life Sciences and advanced technology.

 

The Program and Community Specialist supports and delivers the accelerator and incubator programmes by building and fostering the community and scouting for innovative science ideas.

 

Your role is to provide with implementation and coordination efforts in accelerator programmes. You must be a multi-tasking, super organised leader, ready to focus on all accelerator stakeholders needs.

 

Main Responsibilities

  1. Scouting for technologies and start-ups in life sciences and digital health trough participation in relevant events, fairs, workshops in an online – and physical format
  2. Analysing business plans, innovative technologies, to assess the potential interest of Zcube
  3. Producing reports, dashboards and related presentations on the accelerator and incubator programmes leading exposure at Zcube C-level of management
  4. Planning, developing, and executing mentoring and coaching activities towards start-ups and community
  5. Supporting start-up with the needed capabilities and expertise including project management oversighting
  6. Promoting network with relevant stakeholders, organizations, and companies

Skills / Knowledge

  • Bachelor’s degree in Economics, Management or STEM; Master degree preferential
  • 2+ years of professional experience
  • Project Management skills
  • Proven track record of leading innovation projects with corporates/accademy, ideally a background in consultancy with an innovation twist
  • Experience orchestrating and executing complex innovation programmes and projects is a must
  • Fluent in English and Italian

Characteristics & abilities

  • Passion for start-ups and technology
  • Strong communication and collaboration skills
  • Demonstrates innovative and strategic thinking
  • Multi-tasking abilities

 

You can apply for this position by visiting this link.