CAREERS

Philogen S.p.A. would like to hire an ASSOCIATE PHARMACOVIGILANCE SCIENTIST. The role will report to QPPV/RP and Medical Advisor.

In particular the successful candidate will support the QPPV/RP in:
Assessment, triage and management of the SAE forms.
Preparation of the SAE case narrative.
Management and submission of SUSAR.
Preparation and submission of CIOMS.
Preparation of Ph.V. documentation for Competent Authorities and Ethics Committees.
Preparation and submission of the safety documents (e.g. DSUR and periodic safety reports).
Assistance in data coding using dictionaries.
Revision of SAE and clinical listings to clean safety data, CRA and data manager.
Collaboration in the preparation of the clinical documentation (e.g. Clinical Study Report, Interim Analysis, Internal report, etc.)

The ideal candidate should have:
Bachelor’s Degree in biologic or natural science; or health care discipline.
Postgraduate education in pharmacovigilance and/or previous experience in a similar Pharmacovigilance role are a plus.
Good knowledge of english
Excellent written, verbal and organizational skills.
Strong prioritization skills.
Ability to handle multiple projects and stressful situations.
Good skills in data analysis.

Job location:
Sovicille, 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 a “Clinical Quality Assurance Senior Specialist (GCP)” who will report to the GCP Quality Assurance Manager. The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other functions in the Clinical Department.
 
In particular the successful candidate will be responsible for:
Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.
Review and/or Approval of clinical SOPs and support continuous process improvements
Perform Quality reviews of clinical trial protocols and associated documentation (including informed Consent Documents, CRFs, etc.) as appropriate.
Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures as well as regulatory guidelines.
Report significant clinical quality deficiencies and/or risks to QA management and actively participate in solving the issues.
Perform GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Lead preparation of the company and clinical sites for customer audits and regulatory GCP inspections. Participate as Subject Matter Expert during regulatory GCP inspections
Manage training of staff on company procedures, GCP regulations, and documentation systems.
 
The ideal candidate should have:
A good scientific background (ideally Master/ PhD in Biology, Biotechnology, etc.)
Ideally 3-5 years of experience in Clinical Quality oversight (QA experience in the Pharmaceutical industry required).
A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
A high level of English language, both written and spoken;
A high level of attention to detail;
The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members;
Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.
 
Job location:
Sovicille, 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 accepting applications for the position of Clinical Project Manager to support our Clinical Department.
 
The Clinical Project Manager will support the Clinical Department in the following activities:
Assist clinical study set-up and conduction activities.
Serve as primary project contact with clinical centers. Frequent visits to the clinical center are required to ensure enrolment rate.
Serve as a project management liaison with other groups within the company.
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, CRFs, 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:
A PhD in scientific discipline.
Fluency in spoken and written English.
A Clinical Research background in Pharmaceutical companies or a Global CRO.
Strong communication and coordination skills.
 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
Siena - Italy
 

Philogen S.p.A. is looking for a “GLP Quality Assurance Specialist” who will report to the Company QA 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 assuring that:
 

• Facilities, systems, equipment, methods, quality control procedures, personnel, reports and documentation are in compliance with Good Laboratory Practice (GLP) Regulations.
• Setting up, maintaining and performing a QA program in the Laboratory.
• Assuring that submitted study data to Competent Authorities are accurate, valid and complete. Provide input for responses to regulatory agency questions.
• Conducting Facility audits, Process and Study audits and Computerized Systems audits Study Plan and Study Report reviews.
• Train/ prepare laboratory employees for regulatory inspections.
• Preparing for and Hosting regulatory inspections.

 
The ideal candidate should have:

• A good scientific background (ideally in Biology, Biotechnology, Toxicology, etc.)
• Previous experience in GLP Quality Assurance (at least two years);
• Comprehensive knowledge of GLP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation; GMP and/or GCP experience will be a plus;
• 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 GMP Production Manager who will report to the Plant Manager. This role will be liaising closely with the other departments.
 
In particular the successful candidate will be responsible for:
Developing, optimizing and delivering upstream/downstream fermentation whilst remaining fully GMP compliant.
Keeping the efficiency of his department, premises and equipment, taking care of the maintenance of the production facility and equipment.
Working closely with Quality and Validation to ensure operational and regulatory compliance
Designing and delivering analytical processes to validate the fermentation performance metrics
Coordinating a team of production operators Ensures the training of staff in your department.
 
 
The ideal candidate should have:                                                                                     
-       Excellent GMP experience, with previous mammalian cells fermentation experience in industry A minimum of 5 years’ experience in a similar position in a Pharmaceutical Company.
–      An excellent level of English, both written and spoken.
–      Excellent interpersonal, managerial and organizational skills.
–      A Degree in Biology, Biotechnology or Chemistry.
 
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).
 

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:
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 (SI) - 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:
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 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. would like to hire a Microbiological Quality Control Manager to coordinate the routine tasks of the Microbiological Laboratory, who will report directly to the Qualitu Control Manager.
 
In particular the successful candidate will be responsible for coordinating a team of operators in the following activities:

• Organization of all the activities necessary for the environmental monitoring of the clean room area;
• Organization of the microbiological lab activities and analyses;
• Writing and/or revision of gowning procedures;
• Management of the microbiological lab equipment;
• Raw materials analyses and approval;
• Collection and analysis of environmental monitoring data;
• Coordination of the activities of cleaning in contamination controlled areas.

 
The ideal candidate should have:
Previous experience (at least 3 years) in a similar role.
A good scientific background;
Previous experience in a similar role;
The ability to coordinate members of his/her team;
A good knowledge of the English language;
Comprehensive knowledge of GMP
A high level of attention to detail and with the ability to prioritize working tasks;
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 Pharmacovigilance Responsible. The role will report directly to Head of Clinical Operations.

In particular the successful candidate will be responsible for:
Assessment, triage and management of the SAE forms.
Preparation of the SAE case narrative.
Management and submission of SUSAR.
Preparation and submission of CIOMS.
Preparation of the Communication and Notification to the Competent Authorities and Ethics Committees of Ph.V. documentation.
Preparation and submission of the safety documents (e.g. DSUR and periodic safety reports).
Assistance in data coding using dictionaries.
Revision of SAE and clinical listings to clean safety data, CRA and data manager.
Collaboration in the preparation of the clinical documentation (e.g. Clinical Study Report, Interim Analysis, Internal report, etc.)

The ideal candidate should have:
Previous experience (at least 2 years) in a similar Pharmacovigilance role.
Excellent written, verbal and organizational skills.
Strong prioritization skills.
Ability to handle multiple projects and stressful situations.
Good skills in data analysis.

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 Qualified Person.
The Qualified Person will work at the GMP Facility of the Company, authorized for the production of Experimental biotechnological medicines prepared aseptically.

In particular the successful candidate will take care of:

• covering the duties of a Qualified Person in compliance with the Directive 2001/83/EC and the italian Legislative Decree 219/06.
• Managing the Quality System of the company
• releasing the batches of medicinal product and certify they are manufactured, controlled and documented in compliance with the GMP and marketing authorization.
• Coordinating the other functions of the GMP Facility.

  
Candidates should possess the following profile:   

• BS/MS/PhD in pharmaceutical chemistry, Pharmacy, Chemistry or Biology.
• 3- 5 years’ experience in a Biotech Company exposed to periodic inspection by the Control Authority for authorization to the production and release of drugs.
• Excellent scientific writing skills and fluency of the English language.
• Strong leadership.

 
We offer:
A contract and salary proportional to the experience of the successful candidate.
 
Job location:
 
Sovicille (SI) – 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  Scientific and Medical Writer. The Scientific and Medical Writer will join our Clinical Department and will have responsibility for the preparation of scientific documents including clinical study reports.
Additionally, the selected candidate will be asked to scout and apply for research grants from local and international bodies.

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. BS/MS/PhD in scientific discipline such as medicine, pharmaceutical chemistry, biochemistry,  molecular biology.

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. would like to hire a CHIEF MEDICAL OFFICER for providing medical oversight, expertise and leadership to ensure the strategy, development and implementation of clinical trials, supporting the R&D department in planning product availability for clinical studies.

In particular the successful candidate will be responsible for:

• Provide support in developing strategic plans for the company's product portfolio to ensure development programs.
• Advocate for the health and well-being of our patients.
• Work cross-functionally to define, plan and implement Phase 1-3 clinical studies through clinical proof of concept.
• Develop relations with leading physicians to consult on various topics including Clinical Advisory Boards.
• Develop processes and procedures to ensure the safety and monitoring of our products
• Manage medical/clinical supervision/oversight of individual clinical trials.
• Provide medical input into complaint and adverse event investigations.
• Interface with physicians and/or patients related to medical inquiries associated with our products.
• Support the business development resource to increase the Company’s position in the marketplace.
• Collaborate with opinion-leaders and professional faculty to best design and implement projects.
• Design and write clinical portions of clinical documentations (e.g. protocols, amendments, medical reports, etc.)
• Interact with regulatory agencies and clinical centers in order to support the Company’s development program.
• Participate in Strategy Meetings.
• Appropriately represent Philogen when building and maintaining relationships with partners; ability to build trust and confidence in teams/departments.

The ideal candidate should have:

• A degree in Medicine (mandatory requirement)
• A minimum of 5 years’ experience in a similar position in a Pharmaceutical Company.
• An excellent level of English, both written and spoken.
• Excellent interpersonal, managerial and organizational skills.
• Excellent writing and presentation skills.
• Ability to complete tasks independently and efficiently with attention to detail and in a timely manner.

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).