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Clinical Formulation Scientist - Belgium
Posted on : 02 February 2017
Who Are We:
- We put heart, soul and skills into making a difference for people living with severe diseases.
- Working together to push the boundaries, we blend the best of our talents to unlock innovation.
- To strengthen our Formulation and Process Development team, we are looking to fill the position
Nature and scope:
- Support the overall work in the D4P organization (ex CPhD), e.g. by supporting D4P strategy, by taking responsibilities for continuous improvement and operational excellence initiatives.
- Actively provide strategic guidance for initiation and management of all NCE R&D development programs
- Manage all quality, scientific and technical aspects of internal pharmaceutical development activities
- Ensure a proper and timely evaluation of NCE pharmaceutical formulation and its manufacturing process from FIH clinical stage to market launch
- Ensure an efficient and effective support of CMC activities in coorporation with internal and external customers
- To contribute to department mission and strategy
- To contribute to our strategy in moving our company to a biopharma leader position
- To develop and establish a continuous improvement mindset in order to ensure state-of-the-art products and processes
- To develop proactively creative and efficient solutions for IP protection of Drug Product and Manufacturing processes
2. OPERATIONAL ACTIVITIES RELATED TO CLINICAL FORMULATION ACTIVITIES
- To plan and perform clinical formulation and process development activities by executing from laboratory (e.g. 1-100 grams) to large-scale experiments (few kgs) alone or with the support of technical staff, by providing appropriate documentation and by performing the analysis of data/ results.
- To support the manufacturing of formulations for analytical testing, stability assessment and clinical trial supplies.
- To write development/ technical reports in the context of pharmaceutical development according to department internal policies.
- To analyze process data and develop suitable manufacturing processes compliant with cGMP requirements.
- To apply all relevant regulations, guidelines and operating procedures (quality and safety) in the laboratory work, qualification and validation activities and manufacturing of formulations.
- To be responsible for some instruments/ equipment according to the qualification/validation master plan as assigned (incl. some contribution to qualification work, 1st level maintenance, daily calibration, …etc).
- To support and issue working instructions, Standard Operating Procedures in the field of expertise as assigned.
- To be responsible for the technical/scientific supervision of staff assigned (e.g. formulation technician, contractors).
- To ensure in cooperation with the manager being appropriately trained for the tasks assigned.
Expertise & Skills:
- Min 3-5 years experience (maybe as part of the education) in formulation/process development, scale-up and analysis in the field of clinical development (e.g. solid dosage forms).
- Good understanding of the technical issues that arise during formulation/process development and demonstrated ability to offer solution oriented proposals (e.g. tabletting, wet granulation, spray drying, nanomilling).
- Skilled in analytical techniques common to a pharmaceutical laboratory and in formulation development support.
- Knowledge of GXP principles and good understanding of regulated environment (GLP/GMP).
- Demonstrated ability to continuously update knowledge in all relevant areas of early pharmaceutical development and non-clinical support
- Can work in virtual teams while appreciating different cultures/countries/companies
- Coordinates internal activities in his/her own department for projects.
- Strong planning and organisation skills, including ability to set priorities.
- Demonstrates an ability to help team and others to solve problems
- Provide scientific leadership within specialist area to project team.
- Gives input based on his/her own expertise
- Demonstrates an ability to lead, drive and work with external partners.
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