Job Description
1. Interfaces with External Manufacturing, Technical Development and Manufacturing Science functions and other stakeholders to provide an understanding and appropriate support for new Product technology transfers, and on-going operations for the manufacture of Parenteral Drug Products. Develops and maintains relationships with key stakeholders to promote best practices in the design, construction and operation of Parenteral manufacturing facilities and equipment. Provides general day to day support incl. investigations/deviations, & change controls on commercial products at the CMO’s.
2. Develops and supports strategic initiatives to study/implement new manufacturing partners, methods and technologies, and actively participates in continuous improvement programs. Performs cross-site (internal / external) evaluations to assess equipment and process fit /consistency technical / equipment design approaches.
3. Manages or provides technical oversight for scope definition and engineering studies for capital projects. Provides technical and engineering support and oversight during the scope development, detailed design and execution of capital projects in order to ensure consistency. This involves interacting with or leading multi-disciplined task teams / organizations and includes providing Biogen technical representation and oversight of projects managed by external CMO organizations on behalf of Biogen.
4. Provides evaluations and assessments of equipment and equipment designs, to support vendor selection and new equipment requirements. Provides coordination / assistance and technical input in the design and specification of new process equipment / systems to improve operational performance and compliance.
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Qualifications
• At least 7 years in Parenteral manufacturing or engineering environment.
• In-depth experience and understanding of Parenteral manufacturing operations, equipment and systems. Knowledge of oral solid dosage manufacturing operations is advantageous.
• In-depth knowledge and application of GMP and EMEA regulations.
• Track record of developing or contributing to new project proposals or new technologies in pursuit of corporate objectives, drawing on well‐developed interdisciplinary knowledge.
• Ability to collaborate effectively across functional groups in complex projects
• Excellent oral and written communication skills.
Education
• BSc, MSc in Chemical or Biochemical Engineering or related field.