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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.