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Scientist DPPD & Dev

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Production
Job ID:  64850

JOB SUMMARY

Describe the primary purpose of this role as well as the Geographical scope (Global/Regional/Local) and any regulatory responsibilities

Technical support of biologics in the management/coordination of biological drug product development, especially for all related activities to Drug Product Process Design and Development and in the transfer to GMP manufacturing sites (internal or external).

To support activities for defining and selecting drug product manufacturing processes and components for support to clinical manufacture (from early to late stage projects, e.g. support activities for pre-clinical, stability, Phase 1/2/3 and commercialisation)

Based at UCB Braine

 

 

 

MAJOR ACCOUNTABILITIES

Describe the main accountabilities for this role including significant tasks, responsibilities and projects

•    Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or others

•    Provide all appropriate support to drug product process development activities (eg extractable volume assessment, target fill volume assessment, compatibility assessments, clinical blinding)

•    Support any technical transfer activities up to Phase 3 inclusive

•    Provide support to ensure timely delivery of Clinical trial material to CTSO

•    Ensure products are manufactured in accordance with UCB quality system, cGMP and latest regulatory requirements

•    Provide support to 1st line troubleshooting & process improvement for project up to completion of validation exercise

•    Preparation of protocols and reports in relation to drug product development activities

•    Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes

•    Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities

 

 

 

EDUCATION & QUALIFICATION

Education & experience necessary for this role

Education Level

Describe the minimum level of education necessary for this role:

 

        Bachelor's Degree

        Master's Degree         

        Ph.D.

        Law (J.D.)

        Medical Degree (M.D.)

        Other (Describe):

 

Other Certification

 

 

        Certification (Describe):

        Registration (Describe):

        Licensure (Describe):

        Other (Specify):

 

Experience

List the type and length of experience

 

 

Minimum 2-3 years experience in drug product development and steriles manufacturing within the biopharmaceutical industry is required.

An understanding of the issues and challenges of taking products coming from Research to development process and into clinical manufacture is required.

Good knowledge and technical experience in parenteral liquid and lyophilized product development  and cGMP manufacturing under aspetic conditions would be required.

Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization.

Good knowledge of cGMP and regulatory requirements.

Knowledge of analytical, preformulation and formulation development.

Understanding of antibody drug product manufacturing process and scale-up

 

 

COMPETENCIES

Include specific skills, behaviors and knowledge necessary to meet the objectives of the role

Excellent communication, negotiation and team player skills are required as there will be significant contacts with internal groups and external contractors.

Investigation failure, process improvement, waste reduction, cost reduction

 

 


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