Job Description
We are seeking a dynamic and experienced individual to oversee and guide outsourced (CDMO) upstream process and cell bank-related activities. This role is crucial for the technical development, approval, and lifecycle management of biosimilar drug substance production.
Main Tasks
- Oversee process tech transfer, GMP manufacturing of drug substance, IND application authoring/review of CMC sections, process characterization and validation, as well as authoring/review of CMC sections for BLA/MAA.
- Provide scientific and technical oversight for upstream process development activities at drug substance manufacturing CDMOs.
- Define technical development that adheres to the principles of Quality by Design in accordance with relevant regulatory requirements and guidelines.
- Specify activities required for the preparation of the Statement of Work (SOW) and review associated activities, timelines, and costs at drug substance manufacturing CDMOs.
- Take a leading role in planning and executing USP technology transfer activities, including the handover and scale-up of projects to external GMP manufacturing sites.
- Design and guide process characterization studies and support process validation activities.
- Drive and support upstream troubleshooting and root-cause investigation activities at the CDMO during Technology Transfer, GMP manufacturing, PPQ, and commercial campaigns of approved products.
- Review and approve external technical development protocols and reports; prepare and update Annual Process Development History Reports.
- Prepare, author, and review the relevant CMC sections of regulatory dossiers.
- Serve as the technical upstream subject matter expert for regulatory consultations/interactions, including briefing book and dossier preparation, as well as engaging in the question-response phase with authorities.
- Represent the Upstream Team in cross-functional internal and external meetings.
Qualification Profile
Education & Languages
- A minimum of a Master's or Bachelor's degree in life sciences or engineering.
- Fluency in English; proficiency in French would be an asset.
Professional Skills & Experience
- A minimum of 10 years of relevant experience in the Biotech Industry with a proven track record in upstream processing for biologics, preferably with mammalian cell culture and monoclonal antibody experience. Prior experience with biosimilars is also advantageous.
- Strong technical expertise across the upstream development spectrum, including process development, scale-up and tech transfer, large-scale manufacturing, process characterization, process validation, and lifecycle management of commercial products.
Job Specific Skills & Competencies
- Technical leadership and influencing skills to drive teams to deliver results.
- Collaborative approach, demonstrating engagement and accountability.
- Strong analytical skills with the ability to critically evaluate scientific data obtained at various stages of development.
- Ability to manage multiple projects concurrently with flexibility to shift between them as necessary.
- Strategic thinking that cultivates innovation.
- Willingness to travel up to 20-30% of the time based on business needs, primarily to manufacturing sites and the I&D center located in Switzerland.
- Aptitude for working in a matrix organization.
Apply online using the form below. Only applications matching the job profile will be considered.