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Manager Analytical Development - Biosimilars

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Henegouwen Belgium. Our client is on a mission to make health equally accessible to all. They work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, they create synergies to deliver game-changing production capacities to achieve their mission: Biologics available and affordable to all!

Based in Nivelles you will join a collaborative team of passionate change-makers!

Role description

In particular, our Analytical sciences team is a fast growing and energizing group of multinational and high-level professionals. Your role is to lead the Biosimilars analytical science team, to support the USP/DSP process development and to supervise the execution of in-process control on Biosimlar & Application Projects.

Your goal, together with the team, will be also the implementation of analytical laboratory facilities for biosimilars development pipeline.

Responsibilities

- You will supervise the teamwork and you are able to provide guidance and expertise to advance specific projects and evaluate and propose new technologies and concepts in support of multiple projects;
- You will plan and conduct scientific/laboratory experiments and evaluate and interpret data and supervise the development and validation of analytical methods (ELISA/ TCID50). You will also design and supervise in process control;
- You will report results and/or activities and you will write analytical SOP’s and other documentation (protocols, reports, logbooks);
- You will prepare technical reports and you are able to independently communicate results, presents and defends own work at meetings. You will also deliver updates to senior level management in the context of overall project goals;
- You will comply with all applicable regulations and will ensure that work performed in the area of responsibility is conducted in a safe and compliant manner. You will also maintain proper records in accordance with SOPs and policies.

Requirements

- Master or PhD in Biochemistry or Biotechnologies
- At least 5 years of experience, Analytical or QC, in biosimilar development or biosimilars production environment
- Strong critical thinking, excellent communication and problem-solving skills
- Ability to design, organize, and coordinate scientific research projects
- Act as a leader in absence of supervisor and used to provide training and guidance to laboratory personnel
- Proven knowledge and application of GLPs, ICH, FDA EMA Guidance
- Experience in technology transfer of analytical methods
- Able to multitask effectively and independently
- Innovative and Team player
- Fluent English


Technical skills

- BL3 work (is a MUST)
- ELISA (D-Ag / HCP)
- TCID50/CCID50
- MALS/DLS/NTA, particle characterization
- Others: CE-SDS/SDS-PAGE/WesternBlot/Total Protein

Other information

We offer a long-term contract (CDI), a competitive salary package (health insurance, company car, pension plan, meal vouchers…) and the possibility of evolution in an international, dynamic and fast-growing company.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.

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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 14-03-2019
Country: Belgium
Region: Henegouwen
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Research & Development

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

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Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

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SW1V3PQ London
+44 7307 179882

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