The DP Development Scientist will manage the pharmaceutical development aspects of a biosimilar development project as a drug product subject-matter-expert in a cross-functional team. He will develop and characterize robust manufacturing processes for drug product manufacturing according to QbD principles and internal policies.
Location: Reykjavik, Iceland
Key responsibilities and work assignments:
- Manage the pharmaceutical development aspects of a biosimilar development project as a drug product subject-matter-expert in a cross-functional team.
- Design, perform, interpret and report experiments for the pharmaceutical development of biosimilar pipeline products, specifically leading the development of stable liquid formulations and selection of raw material qualities. Develop and characterize robust manufacturing processes for drug product manufacturing according to QbD principles and internal policies.
- Support drug product process transfers from development to manufacturing.
- Support process validation, specifically driving process risk assessments, attending manufacturing runs, evaluating large-scale data in close collaboration with manufacturing-site team.
- Generate scientific documents, support the generation of international registration documents, support registration activities.
Competencies required to fulfill the employee responsibilities and work assignments:
- An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.
- An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to his/her and do whatever is necessary to solve it.
- It is important that an employee has the company values at heart in his/her work.
- An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to his/her.
- Responsible for following the procedures that the company has established regarding environmental, health and safety issues.
- Education: Min. MSc in biotechnology, biochemistry or similar education. PhD in a related field (such as biotechnology, biochemistry, engineering) desirable.
- Experience: Min. 2 years in a wet laboratory. Experience in protein chemistry highly desirable. Experience in pharmaceutical development or manufacturing of finished dosage forms for biopharmaceuticals highly beneficial.
- Skills: Team player with strong organizational skills. Excellent written and verbal communication skills (English).