CAREERS

SCIENTIFIC AND MEDICAL WRITER

Philogen S.p.A., a Swiss-Italian Biotech Company listed on the Italian Stock Exchange, is accepting applications for the position of Scientific and Medical Writer. The Scientific and Medical Writer will have the main function to scout and apply for research grants from local and international bodies, working in close collaboration with our Research Deparment, based in Otelfingen (near Zurich, Switzerland).

Candidates should possess the following profile:   
 

• Excellent scientific writing skills and fluency of the English language.
• A track record in scientific writing.
• A good understanding of clinical trials.
• Previous experience with grant application.
• PhD or MD degree in scientific discipline such as medicine, pharmaceutical sciences, biotechnology, biology

Job location:

Zurich – Switzerland or Siena – Italy (depending on the personal preferences)

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 a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a special focus on angiogenesis related disorders.

Philogen S.p.A. is looking for a Clinical Data Manager to support the development of the Clinical Department.

 

In particular the successful candidate will give support in the following activities:

• Review and contribute to the development of CRF's and related documents.
• Design eCRF in EDC systems according to study protocol (definition of variable, modules, visits and implementation of validation checks).
• Build, test and validate clinical database.
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures.
•  Review case report forms for completeness and consistency.
• Providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions.
• generating trial data listings and reports on the collected data.
• Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.

 

 

The ideal candidate should have:

· Excellent written, verbal and organizational skills.

· Strong prioritization skills.

· Ability to handle multiple projects and stressful situations.

· Good computer skills.

· Good knowledge of MS Excel and Office package in general.

· Good skills in data analysis.

 

Preferred skills:

· Knowledge of medical terminology with expertise in oncology preferred.

· Knowledge of coding dictionaries (MedDRA, WHO drug).

· Knowledge of programming language

 

We offer:

A contract and salary proportional to the experience (seniority) of the successful candidate.

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).

• Qualifica di Elettricista.
• Esperienza consolidata in manutenzione di impianti elettrici.
• Buona conoscenza del pacchetto Microsoft Office

Philogen S.p.A. is looking for a Corporate Secretary Specialist to join the Legal Affairs Department.
This position will be primarily responsible for providing specialist support in corporate law, particularly with reference to the secretarial activities of corporate bodies, governance obligations, communications with institutional stakeholders, and issues relating to corporate law in general.
 
The successful candidate will mainly be responsible for:
Assisting the governance bodies (Board of Directors, Chairman of the Board of Directors, Chief Executive Officer, Board of Statutory Auditors, Independent Auditors) and providing activities in support of these functions, including the performance of all requisite formalities
Providing assistance to the Internal Council Committees
Calling corporate meetings
Taking minutes of meetings for the committees and governance bodies, and transcribing same in the company books
Preparing and delivering obligatory communications to Consob and Borsa Italiana in compliance with the requirements of a listed company
Examination, analysis, and review of industry-specific regulations
 
Requirements:
Law degree and/or significant working knowledge of corporate law
Knowledge of corporate obligations towards Supervisory Bodies on behalf of listed companies
Fluent in written and spoken English
Working knowledge of Office
Solid experience (at least 3/5 years) in similar role in a publicly-listed company
 
We offer:
A contract and salary proportional to the experience of the successful candidate.

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).

• Sostenere, coordinare ed eseguire attività di convalida CS con fornitori esterni e risorse interne relativamente ad attività che comprendono l'emissione/revisione di protocolli e rapporti di prova, documenti di convalida correlati e inventario.
• Scrivere e revisionare le SOP (procedure operative standard) di sistemi computerizzati relativi ad equipment ed utilities. 
• Occuparsi del mantenimento, attraverso una revisione periodica, di tutti gli status di convalida dei sistemi computerizzati. 
• Collaborare con tutti i reparti aziendali ed il QA per l'implementazione ed il mantenimento di filosofia e comportamenti orientati alla Qualità. 
• Convalidare i Sistemi Computerizzati in ambito Life Science secondo le Best Practice di riferimento GxP e GAMP. 
• Supportare nella gestione degli applicativi (help desk interno) per la corretta implementazione della Data Integrity. 
• Supportare il responsabile nella preparazione e aggiornamento del Validation Plan. 
• Raccogliere informazioni dai diversi servizi coinvolti e redigere i documenti di validazione (reportistica). 
• Collaborare alla valutazione dei protocolli e report provenienti dai fornitori. 
• Interfacciarsi con il QA per la gestione tecnica delle investigazioni e delle CAPA per aspetti di pertinenza nel ruolo. 
• Collaborare nello svolgimento di audit interni e regolatori, per quanto riguarda le attività di convalida e gestione del Data Integrity elettronico. 
• Gestire le anomalie e le pratiche di controllo dei cambiamenti relativi ai Sistemi Computerizzati. 
• Collaborare al training del personale sui Sistemi Computerizzati e sulle tematiche di Data Integrity elettronico. 
• Collaborare con i responsabili di funzione nella scelta dei nuovi Sistemi Computerizzati . 
• Assicurare che tutta la documentazione relativa ai Sistemi Computerizzati sia correttamente conservata.

• Formazione in discipline tecnico/scientifiche. 
• Esperienza di almeno due anni nell’ambito farmaceutico. 
• Esperienza in ambito di preparazione documentazione di qualifica ed esecuzione protocolli IQ, OQ, PQ. 
• Conoscenza di tutte le fasi del ciclo di vita dei sistemi computerizzati, esperienza nelle qualifiche IQ/OQ/PQ ed aver maturato esperienza di Data Integrity e Best Practices GxP. 
• Conoscenza delle normative applicabili in campo medicale con specifiche conoscenze nell’ambito della normativa FDA (CFR 21 parte 11), EU (Annex 11), ISPE (GAMP), MHRA, PIC/S. 
• E’ gradita la conoscenza nel campo dell'automazione (componenti dell'infrastruttura, impostazioni di dominio, sistemi di virtualizzazione, capacità/competenze di programmazione e di gestione di database). 
• Ottima conoscenza del pacchetto Microsoft Office. 
• Buona conoscenza della lingua inglese parlata e scritta

PRODUCTION OPERATORS
For more than 20 years, the Philogen Group has been developing innovative biopharmaceuticals and collaborating with the largest pharmaceutical companies in the world.
We are completing the construction of an additional GMP site in the Siena (Italy) area and are looking for qualified senior and junior candidates who are ready for a new opportunity in GMP production.
 
The successful candidate will be responsible for:

• Performing routine group activities
• Chromatographic purifications
• Fermentation of mammalian cell cultures
• Writing and managing documentation relating to production activities
• Analysis and management of operational flows

 
The ideal candidates will have the following profile:  
Bachelor's degree, MSc or Ph.D. in biology/ biotechnology/Chemical and Pharmaceutical sciences.
Ability to work on cell cultures.
Good knowledge of fermentation techniques and related downstream.
Excellent command of the PC and Office package.
Excellent knowledge of English (able to review scientific journals and attend English-language seminars).
Autonomy in carrying out most upstream and downstream production processes.
Knowledge of technical and scientific terminology.
Previous experience in a comparable role will be considered a plus.
 
Job location:
 
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 Quality Control Operator who will report to the Quality Control laboratory supervisor.

In particular the successful candidate will be responsible for:

• Routine maintenance of cell cultures in laboratory.
• Determines bioactivity and immunoreactivity analyzes
• Carry out chemical or chemical-physical analytical determinations by managing multiple products and using a large number of diversified equipment, both simple (pH meter, Karl F, conductivity meter, etc.) and complex (GC, HPLC, UV-Spectrophotometer, IR, etc.) in compliance with the regulations cGMP / GLP and department procedures
• Preparation of reports and SOPs
• Compiling Data forms, Registers, and Certificates.
• Management and maintenance of laboratory instruments.

The ideal candidate should have:

• A good scientific background.
• Previous experience in a similar role.
• Comprehensive knowledge of GMP.
• A high level of attention to detail and the ability to prioritize working tasks.
• The ability to work independently, as well as coordinate members of his/her team.
• Excellent interpersonal skills and ability to work in teams.

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. would like to hire a Microbiological Quality Control Analyst who will report to the Quality Control Laboratory Supervisor.

In particular the successful candidate will be responsible for:

• Determination of analytical methods: bioburden, bacterial endotoxins and sterility testing
• Determination of mycoplasmastest.
• Environmental monitoring activities of classified manufacturing area (sampling and testing)
• Sampling and testing of water monitoring (Water for Injection, Clean Steam, Purified water and Drink Water)
• Quality control of finished products and samples.
• Preparation of reports and SOPs
• Compiling Data forms, Registers, and Certificates.
• Management and maintenance of laboratory instruments.

The ideal candidate should have:

• A good scientific background.
• Previous experience in a similar role.
• Comprehensive knowledge of GMP.
• A high level of attention to detail and the ability to prioritize working tasks.
• The ability to work independently, as well as coordinate members of his/her team.
• Excellent interpersonal skills and ability to work in teams.

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).
 
 
 

GMP Production SPECIALIST – Team coordinator
Philogen S.p.A. would like to hire a GMP Production Specialist – Team coordinator who will report to the Production Manager.

In particular the successful candidate will be responsible for:

• Coordination of the routine activities of the group
• Good skills in chromatographic purifications
• writing and managing documentation related to the production activities

The ideal candidate should have:                                                                                                                                        
 

• A Degree in Biology, Biotechnology or Chemistry.
• Necessarily previous experience in Production department.
• A high level of attention to detail.
• The ability to work in clean room area.
• Excellent interpersonal skills and ability to work in team.
• Ability to use Microsoft Office software.

 
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 is looking for an IT ASSISTANT who will join our Information Technology team and be involved in the activity of the company’s Information Technology specialists.
 
In particular, s/he will give support in the following activities:

• Maintenance of the PCs and Domain
• Software testing and application performance monitoring
• Design database structure (logical data model) to meet user requirements
• Program databases interfaces in computer languages
• Standard operating procedures updating

The ideal candidates should have the following profile:    

• Technical Diploma  or Computer Science Engineering Degree
• Excellent knowledge of MS Office (Excel package, Word, Power Point, Outlook)
• Solid analytical skills with problem solving ability.
• Good knowledge of English language
• Basic knowledge of VMWare e Windows Server environments is also appreciated

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).

SENIOR REGULATORY AFFAIRS MANAGER
 
Philogen is a Swiss-Italian integrated biotechnology company founded in 1996, with the mission to develop innovative biopharmaceuticals for the treatment of angiogenesis-related disorders.
Philogen would like to hire a Senior Regulatory Affairs Manager responsible for providing strategic regulatory intelligence, guidance and regulatory expertise for product development from clinical through registration and product optimization.
 
In particular, the successful candidate will be responsible for:

• Manage US / EU submissions such as new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.
• Author high-quality documentation and/or review documentation CTD sections, IMPD, BLA, etc. for Health Authority submissions (CTA, MA, etc.).
• Formulate and lead global regulatory strategy for assigned development projects maximizing the business benefit balanced with regulatory compliance.
• Maintaining knowledge up to date of all current applicable regulations and proactively participating in the design of global regulatory strategies.
• Making sure that all necessary documentation is completed and submitted in compliance with applicable government regulations.
• Acting as the liaison with other Philogen divisions keeping each department informed of applicable regulations and monitoring compliance.
• Acting as the liaison between Philogen and the Regulatory Authorities on CMC related topics. Leading preparation of meetings with regulatory agencies as needed and ensure regulatory issues impacting global regulatory strategy for proposed marketing filings are considered.
• Assist during regulatory agency inspections.

Requirements:

• Degree in a Life Sciences discipline.
• Previous experience as a Regulatory Affairs manager, ideally with significant experience in the regulatory submission and approval processes for new medicinal products.
• Effective verbal and written communication skills in order to keep other managers and department heads informed of regulations and policies that require compliance.
• Problem solving and strategic planning skills.
• An excellent level of English, both written and spoken, to enable the correct completion of reports and documentation required by regulatory authorities.
• Good interpersonal skills and able to work effectively both in cross-functional teams and independently.
• Attention to detail, and capacity to follow projects through to completion.  
• Experience with CMC regulations for parenteral drug products.

 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Sovicille (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).
 

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

• Biochemical, Microbiological and Viral QC laboratory functions and the corresponding documentation to support the timely disposition of product.
• Overall Quality control disposition of incoming materials and finished products.
• Analytical method set-up and writing reports.
• Reviewing and approval of the entire SOPs relating to Quality control tasks and ensuring understanding and implementation of these SOPs.
• Insuring compliance of laboratory procedures and practices with Philogen Quality standards and with GMP and GLP regulations.
• Supporting laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
• Management of site products stability studies.
• Facilitating continuous improvement in QC day to day operations and general systems and will actively support achievement of plant goals.
• Coaching and developing QC colleagues to achieving high performance.

 
The ideal candidate should have:

• A good scientific background.
• People management experience.
• Comprehensive knowledge of GMP.
• Minimum 5 years’ experience in Quality Control management in pharmaceutical industry field.
• Knowledge of the following analytical techniques: E.L.I.S.A immunoassays, SDS-PAGE Electrophoresis, Size Exclusion Chromatography/ Cation Exchange by HPLC, Bacterial Endotoxins determinations, cells proliferation assay, cell culture, real time PCR.
• High analytical skills.
• Communication & high interpersonal skills.
• Problem solving skills.
• A high level of attention to detail and the ability to prioritize working tasks.
• Good English knowledge.

 
We offer:

•  A dynamic environment.
• A permanent contract with a salary proportional to the experience level of the successful candidate.

Job location:
Sovicille (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 looking for a “GMP Quality Assurance Specialist” 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:
Monteriggioni (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).
 

BIOSTATISTICIAN
 
Philogen S.p.A. would like to hire a BIOSTATISTICIAN to support our Clinical Department.
 
 
Responsibilities:
Develop study design and data analysis plans.
Execute statistical analyses for clinical trials (e.g. sample size calculation, interim analysis design, PK  analyses, etc.)
Write the statistical analysis plans and produce statistical reports related to trial execution
Provide statistical expertise in analysing and modelling clinical data.
Analyse, evaluate, and report on complex observations related to clinical data.
Provide active support in producing data listings and summaries.
Good experience with statistical software packages such as R and SAS.
Excellent written communication skills.
 
 
Requirements:
A graduate degree in biostatistics or mathematics.
Strong mathematical and statistics skills
Problem solving
Flexible attitude to work on different tasks
Written and oral communications skills
Strong teamwork skills
Critical thinking
Solid knowledge of R and SAS
Strong computer background (it represents a plus the knowledge of additional programming languages)
 
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).

 

PLANT MANAGER & QUALIFIED PERSON 
Philogen S.p.A. is accepting applications for the position of Plant Manager. The Plant Manager may also serve as Qualified Person.
Plant Manager reports directly to Philogen’s CEO and directs and manages all plant operations. 
The Plant Manager is responsible for the day to day operations of a sterile products manufacturing facility.  The role provides daily leadership to the fulfillment of GMP development and production activities as well as other support functions in compliance with applicable GMP regulations.
The Plant Manager also works collaboratively with other Business Units to scope, plan, and execute new business opportunities.

In particular, the successful candidate will take care of:

• Directing and managing plant operations for Production, Maintenance and Quality in the development, scale-up and technology transfer of products, including the production of cGMP products for clinical testing.
• Coordinating plant activities through the planning with departmental managers to insure the total manufacturing objectives are accomplished in a timely and cost-effective manner.
• Establishing and monitoring overall plant performances for production and quality standards according to good laboratory practices (GLP) and current good manufacturing practices (cGMP) guidelines.
• Providing leadership and training to accomplish the company goals and objectives.
• Implementing and maintaining preventative maintenance programs.
• Providing direction, development and leadership to the Production Manager.
• Planning the set up and qualification of a new Plant

 
Candidates should have the following profile: 

• Proven experience in the management of a GMP plant
• Proven experience with inspections by the Competent Authorities for relevant authorizations of the production and release of drugs.
• Proven experience in the GMP production of proteins or biologics.
• BS/MS/PhD in Pharmaceutical Chemistry, Pharmacy, Chemistry, Biology, Medicine or Veterinarian Medicine.
• At least one year of experience in the Quality Control unit of a plant authorized to the production of medicinal substances. 
• Excellent scientific writing skills and fluency of the English language.
• Previous appointment as Qualified Person of a plant authorized to the production of medicinal substances is preferred but not mandatory.

 
Work Location:
Siena area

Interested candidates are asked to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003, to the e-mail address: jobopportunities@philogen.it.