Bioloog medisch m-v

Our client is headquartered in the uk and founded in 2000. it is a world class outsourcing partner to the pharmaceutical and biotechnology industry and offers a full range of services from early phase product development, through critical trial packaging to high volume commercial manufacturing. the group operates globally with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites across europe and north america. the braine l'alleud site located near brussels, has extensive know how in contract manufacturing, packing and the control of cytotoxic products gained over many years. the new sterile product development centre (spdc) supports customers' projects from pre-formulation and formulation development through to clinical development and manufacturing for phase i and phase ii clinical trials with scale-up capability, in accordance with the highest regulatory requirements. in order to enforce his team our client is looking for a:


responsible analytics sterile product development center (spdc)


key areas of responsibility:
- resources management:
- staff: optimization, coaching, objectives, policies/procedures follow-up
- equipments

- budget establishment and cost tracking of the section; investment proposal; in order to meet financial target, identify possible gaps and propose solutions

- managing the analytical part of development projects:
-quotations
-discussion with clients
-determination of analytical specifications
-planning and follow-up of the work of the team
-analytical release
-methods transfer
-methods validation
-stability studies

- management and implementation of control procedures (gmp and fda compliant)

- authorities and customers audits: participation, follow-up, capa, kpi

- management of pq / routine checks for utilities, environment and personnel

- reporting


person specification:
reporting to the spdc unit director, you will have:
-an outstanding analytical background, including experience in biologics and high potency drugs testing
-experience of quality control and validation techniques for drugs manufactured in a sterile environment
-experience of planning for and managing quality control functions and personnel
-good leadership skills and the ability to organise resources to fulfil commercial and technical requirements
-the capability and expertise to present analytical information to external and internal customers
-turned on customer, to be a real technique help for sales team
-experience of the us pharmaceutical market and dealing with glp/fda requirements
-strong project management skills
-fluency of french and an excellent command of english
-the ability to interface with senior managers and executives within nextpharma's product development and executive teams.


offer:
a pivotal role in the establishement, leadership and ongoing management of the new product development centre for sterile product dosage forms at the braine l'alleud site (near brussels, belgium). you will be an active member of a young and energetic company with global reach focused on supporting the customers with the latest technologies, where you can make a real difference.


interested?
please send us your cv cover letter at j3g7zn62kwq4jj3wslm_cbnv~false^excp@apply.cbdr.com

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