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Product Transfer Project Manager
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Engineering, Support
Projektbeschreibung
One of our clients, an international company in the pharmaceutical industry currently requires a Product Transfer Project Manager
Start: 1/1/2015
Length: min. 6 months + extended
Location: South of Brussels
Product Transfer Project Manager
FUNCTION DESCRIPTION:
Transfer coordination of production activities (primary/secondary) to a partner (Licensee)
KEY RESPONSIBILITIES:
Transfer bacterial vaccine process to a partner (licensee):
- Seed preparation process and bulk production process (upstream and downstream),
- Coupling and formulation process
- Filling and Lyophilisation process
- Labelling and Packaging process
- Write and have approval of transfer documents,
- Establish all production process flow
- Prepare and manage all the meetings and documents related to the project (agenda, minutes, connectware, TC..)
- Ensure the availability of the all documentation required to support the transfer (BR, SOP, MOP, .). Generate and update all necessary document according to the transfer procedure ( URB, validation package).
- Assist in logistic process of Raw Material, Elaborate the budget and control the timelines and costs
- Make regular project reports to the project leader
- Coordinate with all stake holders to have a complete alignement of the team members
- Make Powerpoint presentations to the stakeholders
- Be creative to have motivated and committed team
EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED
Education
* University degree in Biology or in Engineering (or equivalent by experience)
Knowledge
* Fluent in French and English (spoken and written)
* Experience of pharmaceutical environment and requirements (Primary production, Packaging, Filling, cGMP, Validation, Procedures, )
* Scientific and technological know-how related to vaccine manufacturing and secondary operations (filling and packaging).
* Expertise in vaccine products/secondary activities
* Flexibility to face rapidly changing environment in vaccine development.
* Project management skills.
Experience/Behaviors/Skills
* Good communication skills
* Good analytical skills; ability to analyze user needs and challenge them in a positive way
* Autonomous, Rigorous, Structured, Systematic, resilience
* Understanding of business environment of Licensee and ability to workin this context
* Ability to work in team in a cross-departmental, multidisciplinary environment; lead and impact cross-functional team members
* Quality oriented
* Have already demonstrated success in transfer processes know how is a plus
Tags: Manufacturing, pharmaceutical, pharmaceutique, bulk, vaccines,project management
Start: 1/1/2015
Length: min. 6 months + extended
Location: South of Brussels
Product Transfer Project Manager
FUNCTION DESCRIPTION:
Transfer coordination of production activities (primary/secondary) to a partner (Licensee)
KEY RESPONSIBILITIES:
Transfer bacterial vaccine process to a partner (licensee):
- Seed preparation process and bulk production process (upstream and downstream),
- Coupling and formulation process
- Filling and Lyophilisation process
- Labelling and Packaging process
- Write and have approval of transfer documents,
- Establish all production process flow
- Prepare and manage all the meetings and documents related to the project (agenda, minutes, connectware, TC..)
- Ensure the availability of the all documentation required to support the transfer (BR, SOP, MOP, .). Generate and update all necessary document according to the transfer procedure ( URB, validation package).
- Assist in logistic process of Raw Material, Elaborate the budget and control the timelines and costs
- Make regular project reports to the project leader
- Coordinate with all stake holders to have a complete alignement of the team members
- Make Powerpoint presentations to the stakeholders
- Be creative to have motivated and committed team
EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED
Education
* University degree in Biology or in Engineering (or equivalent by experience)
Knowledge
* Fluent in French and English (spoken and written)
* Experience of pharmaceutical environment and requirements (Primary production, Packaging, Filling, cGMP, Validation, Procedures, )
* Scientific and technological know-how related to vaccine manufacturing and secondary operations (filling and packaging).
* Expertise in vaccine products/secondary activities
* Flexibility to face rapidly changing environment in vaccine development.
* Project management skills.
Experience/Behaviors/Skills
* Good communication skills
* Good analytical skills; ability to analyze user needs and challenge them in a positive way
* Autonomous, Rigorous, Structured, Systematic, resilience
* Understanding of business environment of Licensee and ability to workin this context
* Ability to work in team in a cross-departmental, multidisciplinary environment; lead and impact cross-functional team members
* Quality oriented
* Have already demonstrated success in transfer processes know how is a plus
Tags: Manufacturing, pharmaceutical, pharmaceutique, bulk, vaccines,project management
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges