jueves, 21 de enero de 2010

[OFER] NAC: Job offer biomanufacturing director

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---Procedencia:
Institución:Innovative Bioconsulting
Contacto correo-e:consultoria@innobc.com
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Ref. 0101

Our customer is looking for a Senior Technologist/Scientist to direct its Biomanufacturing operations and in this role, you will implement innovative GMP processes for viruses and therapeutic proteins and ensure scale-up, validation and technology transfer from the R&D teams up to the 250 l scale. In close interaction with the R&D process development teams, you will be responsible for the hands-on, day to day management of GMP manufacturing operations using state of the art production and purification technologies.

Responsibilities

The position will report to the CTO, and be based in France close to Nantes. Working closely with the CTO, the role will encompass responsibility for all day to day operational activities within Biomanufacturing, the upstream, downstream and maintenance groups and projects leadership. It will necessitate the training, development and leadership of the team, currently 7 in number but expected to grow along with the growth of CMO business. It will require a person with a full understanding of biologics pharmaceutical development for the manufacture of therapeutic protein and viral vaccine IMPs according to GMP. Taking into account future full scale manufacturing operations will be essential.

The main responsibilities are as follows:
• Develop and submit for approval by the Management and execute a detailed annual plan that will address the Biomanufacturing activities that are required for the production of preclinical and clinical batches of protein and vaccine candidates in support of commercial activities for the company; ensure that such processes can be further upscaled to larger volumes
• Ensure that all plans and programs underpin and support the business objectives of the Company and are efficiently and effectively managed;
• Develop a world class biomanufacturing team that is able to interact both internally and externally and allow the company to grow it's skills within this sector;
• Ensure that all biological processes and products meet current and future regulatory requirements for clinical manufacturing, validation and scale up; apply Quality Risk Management and Pharmaceutical Development principles;
• Support the commercial activities of the Business Development team in front of potential customers, potential partners, as well as external scientific experts;
• Manage, with the business development team, the relation and the reporting with the CMO clients.
• Be involve in most of the project teams that include biomanufacturing
• Be Project leader for some projects such as the current Geovax or Innate projects
• Promote scientific excellence, ensure the integration of the biomanufacturing group within the company, and in particular ensure a close interaction with the R&D process development teams;
• Ensure correct technology transfer and develop systems to ensure that GMP implementation is smooth and consistent;
• Develop new product development plans and ensure both buy-in by the CSO, CTO and company management;

The Person
In view of the wide range of responsibilities the ideal candidate will have the following qualifications and experience:
• A PhD in a life science subject, ideally Biochemical Engineering, Fermentation /Cell Culture Technology or Microbiology
• 10 years experience in a clinical manufacturing and pharmaceutical development role within the industry sector
• Ideally, experience of a small company to understand the limitations this brings on both resources and expenses
• A proven track record with all activities related to pharmaceutical development: the development, validation, scale up and transfer to GMP manufacturing of downstream processes to produce highly purified and potent biological IMPs (vaccines and therapeutic proteins)
• State of the art knowledge and extensive experience in fermentation, cell culture, cell disruption, filtration, and chromatography technologies (Multiple Use Systems and Single Use Systems), qualifications and experience with Design of Experiment optimization : definition of Process Design Space
• Knowledge and experience of the appropriate regulatory environment for vaccine and therapeutic protein manufacture
• A proven track record for the technology transfer and scale up of biologics processes from research to 250 L scale
• Experience of project management and previous experience and familiarity in development and management of budgets
• A good understanding of the finance process implied in the development organization
• Have proven experience in the development and justification of new product needs, and an ability to think "out of the box"
• Ideally previous experience of leading small interactive teams

The personal qualities of the individual will be as important as his/her qualifications and experience. These should include:
• The positive and enthusiastic personality required of a successful leader and the energy, drive and stamina to bring projects to a successful conclusion;
• The clarity of thought and infectious enthusiasm needed to act as the "champion" of the Biomanufacturing Team;
• The presence, maturity and credibility to make an immediate and sustained impact within the Company as well as with external stakeholders;
• A "hands-on", adaptable and flexible approach, comfortable working in a small team, but with the ability to grow and develop as the needs of the company change;
• An ability to be both a good listener as well as the ability to 'challenge' the organization.
• Excellent interpersonal skills, the ability to build relationships with external collaborators, opinion leaders, lobby groups, as well as internal groups;
• Excellent presentation skills, to both in-house staff and external groups;
• Result orientated, but with the ability to set realistic targets for both his/her own team and others;
• Ability to travel, as needed for the position
• Fluency in English, both written and oral are essential, additional languages, especially French are highly desirable.

REWARDS
• A direct and personal impact on the future shape and success of the Company;
• A competitive salary
• Bonus scheme for achievement of goals.
• Stock Option Plan

OUR CUSTOMER
The company spent the next few years developing a recognized scientific and technical expertise in avian ES cells, with the aim to apply these technologies to genetically improve avian species of commercial interest.
The work on ES cells did not provide the potential originally envisaged for avian transgenesis but it was identified that avian ES cells held a tremendous potential for the commercial production of human and veterinary viral vaccines. In 2003, the team focused on these industrial applications and obtained the first commercial licenses
These achievements drove the development of the commercial value of the company and the company was able to successfully carry out an IPO in 2007 which was 7 times over subscribed. The company is in a very strong position since with current commercial licenses in place and the funds raised via the IPO, the company has in excess of 4 years cash. By focussing on proprietary processes and technology platforms, they could develop a strong business model of Up-Front and Milestone payments, coupled to a significant license royalty fee. The current business plan of the company is to further develop the vaccine and protein manufacturing sector, but also based on research and development already performed, to move into the co-development and development of proprietary products for the vaccine and therapeutic protein areas. The company is already actively involved in the co-development of an anti-cancer monoclonal antibody and a recombinant vaccine against an infectious disease, and i!
ts development team is currently being further expanded. Major additional deals with leaders in the vaccine industry have now been signed with licensees such as GSK, CSL, Kaketsuken and Intervet.


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Información complementaria de la oferta:
IF YOU ARE INTERESTED IN THIS JOB OFFER, PLEASE SEND US YOUR CV TO consultoria@innobc.com If not, please, feel free to share it with your contacts.

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