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Job: Head formulation development (injectable) M / F

General information

business
Company 
Pharmaceutical
RESEARCH INSTITUTE PIERRE FABRE SAS

 

Job Description

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Job Title
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Europe
France
Midi-Pyrenees
Toulouse - Langlade (31)
Galenic development manager (injectable) H / F
CDI
Full-time
Within the platform Industrialization of R & D PFM, in your capacity as referent in the formulation and processes for injectable products, you are supporting the development of all the injectable forms entrusted to the Pharmaceutical Engineering Department Forms and Processes (IFPP) and that assessing applications OPHRDC.
You drive industrialization projects (all laws) entrusted to you in scientific term, documentary, planning and compliance processes. You participate in the expertise and scientific advice on all matters CMC back to the platform Industrialization.

As such, you :
  • Take charge of the realization in internal and / or outsourced technical actions selected for the development of injectable formulations and processes, after assessment and recommendations, in accordance with the processes in place;
  • Establish close cooperation with the relevant industrial sites for joint technical analysis of industrialization injectables trials;
  • Bring your technical expertise to technicians in charge of managing the pilot injection tool;
  • Participate in the evaluation of requests from the OPHRDC;
  • Participate in the animation of the pharmaceutical community in order to improve the skills and services rendered, in close cooperation with the formulation development of Platform Manager New Chemical Entities (NCEs);
  • Are referent to develop approaches Quality by Design (QbD) on development projects;
  • Participate in the management process of industrialization in the project portfolio (all dosage forms) for an overview of the required / acquired / left to do from a scientific point of view documentary, planning on the part Drug Product;
  • Join the expertise and scientific and tactical recommendations on CMC issues dating back to the Industrialization Platform from the Innovation Unit / Development Teams (CHC, NEC or NEB), the CDMO, the Industrial or Compliance through appropriate scientific and methodological approach;
  • Develop a network of experts and scientific partners to address the issues in the field of injectables.

 

PROFILE
PhD in Pharmaceutical Sciences (formulation chemistry, physical chemistry) or Chemical Engineer / Pharmacist
specialized formulation.
Demonstrated experience 5 years minimum in the pharmaceutical development of injectable formulations and processesincluding industrialization of the finished products missions.
pharmaceutical engineering expertise (processes studies and transposition of scale factors) for formsinjectables.
Knowledge of international standards and guidelines (GMP, GMP, ICH ...) and expectations of authoritiesguardianship (FDA, EMA, ANSM).
Ability to transverse management and multi-project management at all stages of development.
Fluent English.

You are known for your strong scientific curiosity, your capacity for innovation, responsiveness, your mindteam and your sense of the result.


candidate criteria

Minimum level of education required

Diploma

Science specialty

Minimum Experience Level

required

Languages
Bac + 4 / 5 Bac +


4-Master / Master / DEA / DESS / ESC / Engineer

Science - Chemistry, Science - Engineering formulation

5 years or more



English (4 - Current)


Date of taking officedesired:01 / 07 / 2017
Apply by following this link:http://www.pierre-fabre.com/fr

 

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