CAREERS

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).