CAREERS

Philogen S.p.A. is looking for a “GMP Quality Assurance Operator” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System.
 
In particular the successful candidate will be responsible for:

• writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
• revision of production and quality control batch records;
• managing GMP QA operations, change control, deviation and documentation systems;
• identifying and recommending future improvements;
• implementing action plans;
• developing quality strategies and priorities and translating them into short and long-term objectives;
• risk assessment;
• interacting with other members of the company and clinical center staff.

 
The ideal candidate should have:

• A good scientific background (ideally in Biology, Biotechnology, etc.)
• Previous experience in Quality Assurance (at least three years);
• Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
• A high level of English language, both written and spoken;
• A high level of attention to detail and with the ability to prioritize working tasks;
• A strong flexibility in changing tasks and priorities;
• The ability to work independently as well as coordinate members of his/her team;
• Excellent interpersonal skills and ability to work in teams.

 
Job location:
Siena
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

Philogen S.p.A. would like to hire a QUALITY CONTROL OPERATOR who will report directly to the Quality Control Manager.
In particular the successful candidate will be responsible for:
 

• Routine Quality Control on “in process” or Final Product samples, such as:  E.L.I.S.A immunoassays, SDS-PAGE Electrophoresis, Size Exclusion Chromatography by HPLC
• Drafting of protocols, reports and Standard Operative Procedures (SOPs)
• Working in compliance with the GMP ensuring the efficiency of the department
• Management and maintenance of laboratory instruments.

The ideal candidate should have:

• A good scientific background.
• Comprehensive knowledge of GMP.
• A high level of attention to detail and the ability to prioritize working tasks.
• The ability to work coordinating with the members of his/her team and the department manager. 
• Excellent interpersonal skills and ability to work in teams.
• Good English knowledge 

We offer:
A contract and salary proportional to the experience (seniority) of the successful candidate.
 
Job location:
Siena -Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

Philogen S.p.A. seleziona, per il proprio ufficio amministrativo

 ESPERTO/A CONTABILITA' E BILANCIO
 
La risorsa sarà inserita all'interno del dipartimento amministrativo rispondendo direttamente al CFO e si occuperà in particolare di:

• Ciclo passivo e tesoreria
• Contabilità generale ed analitica
• Predisposizione delle scritture di rettifica di fine anno
• Adempimenti contabili fiscali ed amministrativi richiesti dalla mansione
• Controlli interni ed interazioni con gli uffici del gruppo attinenti

 
Requisiti richiesti:

• Diploma di ragionieria o laurea in discipline economiche.
• Conoscenza di principi contabili italiani, normativa iva anche intracomunitaria, fatturazione elettronica.
• Costituirà titolo preferenziale una precedente esperienza in società di revisione o società/studi professionali organizzati.
• Ottima conoscenza della lingua inglese.
• Ottima padronanza del pacchetto Office.
• Precisione e capacità di lavorare in autonomia.
• Attitudine al lavoro in gruppo e per obbiettivi.

 
Offriamo:
Un contratto ed un inquadramento proporzionale all'esperienza del candidato prescelto.


Sede di lavoro:
Sovicille (SI)
 
 
 
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Philogen S.p.A. would like to hire a Specialist for the GMP production of therapeutic recombinant proteins.
The Specialist is responsible for ensuring quality oversight with a particular focus on the quality by design of the whole manufacturing process from cell-culture to final formulation.
The ideal candidate will work closely with product development and the manufacturing teams. His/her position requires expertise in all aspects of product manufacturing, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment.
 
In particular the successful candidate will be responsible for overviewing:

• Development of small-scale fermentation process;
• Scale up and optimization of fermentation process;
• Small-scale and large-scale chromatography;
• Fill and finish techniques;
• Writing documentation of production activities.

The ideal candidate should have:                                                                                                                                              

• Msc in Scientific Discipline such as Biology, Chemistry or analogue discipline. A Ph.D. in the field is preferred.
• A proven and well documented experience in the field of expression and characterization of recombinant proteins. Experience in the pharmaceutical industry is preferred but not mandatory.
• Excellent oral and written communication skills
• A high level of attention to detail.
• Excellent interpersonal skills and ability to work in team.
• Ability to use Microsoft Office software.
• Fluency in English language.

 
We offer:
 A contract and salary proportional to the experience (seniority) of the successful candidate.
 
Job location:
 Siena - Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
 

Philogen S.p.A. is accepting applications for the position of MEDICAL ADVISOR for the development of clinical experimental activity. The successful candidate will have the responsibility for supporting the management of Philogen’s clinical trials in oncology and rheumatology. 
 
In particular the successful candidate will be responsible for:
Collaborating with opinion-leaders and professional faculty to best design and implement clinical projects.
Providing support in designing and writing clinical portions of IND documentation including protocols, amendments, medical reports, safety and efficacy summaries, scientific rationales, interim and final reports.
Providing support in monitoring efficacy and safety trends by reviewing clinical data. Interacting with Principals Investigators and clinical site staff to advance the performance of clinical trials.
Interacting with regulatory agencies and clinical centres to support the Company’s development program.
Participating in Strategic Meetings.
 
The ideal candidate should have:
A degree in Medicine.
An excellent level of English, both written and spoken.
Good interpersonal skills
Ability to build trust and confidence in teams/departments
Ability to work independently.
 
 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Siena - Italy
 
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Philogen S.p.A. is accepting applications for the position of CLINICAL PROJECT MANAGER for the development of clinical experimental activity. 

In particular the successful candidate will be responsible for the following activities:
Assist clinical study set-up and conduction activities.
Budget management.
Define a plan for achieving project timelines and deliverables based on information from the other clinical functions.
Serve as primary project contact with clinical centers. Frequent visit to the clinical center are required to ensure enrollment rate.
Serve as a project management liaison with other groups within the company.
Supervise maintenance of project management information and tracking systems.
Assist in site selection and pre-study activities to identify and evaluate potential investigators.
Support regulatory activities necessary to start and conduct the clinical trial in each involved investigational site.
Assist with the development of study specific project plan, monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents in cooperation with the other Department involved (i.e. data management, safety, medical writing).
Provide active support in patient's enrolment strategies with the project team and the study site coordinator.

The ideal candidate should have:
2-4 years of experience in the management of international studies.
A MSc/PhD in chemistry, pharmaceutical chemistry, biochemistry, molecular biology or similar field. A MSc in Medicine would be preferable. 
A Clinical Research background in Pharmaceutical companies or a Global CRO.
Experience in Trial Master File and Clinical Management Monitoring systems.is fluent in English.
Strong communication and coordination skills.

We offer:
A contract and salary proportional to the experience of the successful candidate.

Job location:
Siena/Zurich - Italy
 
Interested candidates are kindly asked to send their Curriculum Vitae, including the title of the position in the subject line, to the following address jobopportunities@philogen.it, authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Philogen S.p.A. would like to hire a CLINICAL RESEARCH ASSOCIATE  for the development of clinical experimental activity. The successful candidate will have responsibility for the management of Philogen’s Phase I and II clinical trials in oncology and inflammatory diseases. He/she will be expected to make frequent visits to European centres involved in clinical trials.
 
In particular the successful candidate will be responsible for:
Dossier preparation and submission following international guidelines.
Management and evaluation of clinical data.
Monitoring of national and European centres involved in the clinical studies.

The ideal candidate should have:
A good scientific background.
An excellent level of English, both written and spoken
A good level of German language would be preferable
The ability to travel frequently.
A high level of attention to detail.
The ability to work independently.
 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Siena -  Italy
 
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).