French brochure
 English brochure

Job Opportunities

March 2010: Protein’eXpert is looking for a head of GMP Production

Company
Funded in 2000 PX’Therapeutics is an expanding Contract Research & Manufacturing Organisation located in Grenoble and Lyon (France) and with a sales office in Cambridge (MA, USA). The company is devoted to recombinant protein engineering & production for biomedical research applications. Our 50-staff company offers custom-designed services focusing on the discovery, optimisation and production of valuable target or therapeutic proteins.
Recognised as a leading European player in the field of recombinant proteins manufacturing, PX’Therapeutics possesses extensive expertise in protein expression, purification and folding in several expression systems (E. coli, yeast, insect and mammalian cells).
Since 2004, PX’Therapeutics has extended its offering to the biomanufacturing of therapeutic protein products for early clinical trials (Phase I and II) via its business unit PX’Pharma. PX’Pharma provides dedicated contract services for process development & scale-up optimisation, pre-clinical and clinical cGMP production. In 2007, PX’Therapeutics extended once again its offering via its business unit, dedicated to monoclonal antibodies development and production. The combination of PX’Therapeutics, PX’Pharma and PX’Monoclonals know-how and manufacturing capacities allows ensuring a seamless transfer from therapeutic protein development up to clinical production stages.
Over the five past years, the company has demonstrated its capability to tackle highly complex and recalcitrant protein projects and take them to production stages. PX’Therapeutics has indeed been working on more than 200 protein related projects, gathering expertise on various target and therapeutic proteins and building up effective technologies as well as superior management skills.
PX’Therapeutics complies with ISO 9000:2000 international quality standards. The PX’Pharma facility and equipment have been inspected by AFSSAPS (France) and comply with the French and European (EMEA) GMP guidelines. PX’Therapeutics is one of the first biopharmaceutical manufacturers operating in France to be authorized to release cGMP-grade therapeutic protein candidates.

With the constant expansion of our company and due to the implementation of a new production platform based on mammalian cells technologies, PX’Therapeutics is looking for a Head of GMP production. The post would be based in Grenoble, France.

The position
The post holder will report to the CSO, and will liaise closely with the Pharma Quality Director.
He/She will be responsible for the process development, scale up optimization, preclinical and clinical cGMP production of therapeutic recombinant proteins, including antibodies, in mammalian cell, bacterial and yeast systems.  This will include responsibilities for ensuring each Project is performed in accordance with cGMP regulatory requirements.
More especially, he/she will be responsible for new technologies selection, validation and implementation, staff training, scientific and technical troubleshooting, as well as involved in facilities management, production equipment qualification and validation.
In addition, he/she will manage a multi-disciplined team of scientists.
Together with the Project Directors team, he/she will be also involved in the evaluation, planning, management and follow up of therapeutics projects, ensuring objectives and milestones are met on time and on budget.

Candidate’s Qualifications and Experience
• An MSc or PhD degree in biotechnology, biology, biochemistry or cellular biology.
• Between 5 to 15 years experience in the biotechnology industry with strong background in production of therapeutic recombinant proteins, in GMP environment.
• Good knowledge of cGMP regulatory requirements.
• Previous experience in mammalian cell cultures (CHO,HEK, vero, avian, primary cells, etc), process development, production (USP), purification (DSP) including technology transfer and scale up, applied to the preparation of Therapeutic proteins, including antibodies but also, viruses and or viral vectors.
• Strong organizational and communication skills.

Contacts
To apply, please send your application (covering letter + CV) with the quoted reference “HEADGMP" to the attention of Delphine PAU, in charge of Human Resources.