Senior Expert/Functional Lead (Biologic Drug Products)

Job Description Summary

Job Description

Your responsibilities:

As Functional Lead you will lead, own and drive all deliverables within complex Biologic Drug Product development projects and you will be a core member of the Drug Product development sub-team, representing the scientific and technical excellence.

Your responsibilities as Functional Lead will be to:

• Independently design, plan, supervise and/or execute technical and scientific activities for the assigned project(s) in close alignment with the respective project manager(s) and in close collaboration with the lab scientist(s).
• Interpret results from scientific / technical activities including drawing relevant conclusions and presentation of data to relevant sub-teams as required. You will deliver development work packages to meet agreed objectives & timelines in the project team and you will ensure and drive the information exchange in the Drug Product sub-team.
• Plan, prepare and provide required information for clinical Drug Product supplies to the clinical manufacturing sites internally or externally with support of project leader. Furthermore, you will support technical and clinical manufacturing campaigns throughout the development phases of the assigned project(s) with technical expertise on formulation and process.
• Drive and support Root Cause Investigations (RCIs) as well as trouble shooting activities including development of solutions, mitigation plans and report risks or issues to the project manager and/or any other relevant team member or line unit.
• Write and review key development documents and reports which are used to prepare regulatory CMC documents. Furthermore, you will support reviews of regulatory CMC documents and contribute to interactions with health authorities.

In your role as Functional Lead, you will further support the Drug Product Science Team with the following responsibilities.

• Lead or contribute to key scientific initiatives and workstreams to develop short- & long-term drug product development strategies for the Biologics pipeline.
• Lead or contribute to innovation initiatives with strong focus on implementation of data & digital in our daily development work.
• Present scientific or technical results to different audiences within or external to Novartis.
• Work according to appropriate laboratory standards for quality, ethics, health, safety, environment protection and information security.

What you’ll bring to the role:

• Ph.D. in Chemical or Biochemical Engineering, Pharmaceutical Technology, or equivalent.
• 2-5 years of experience in biotech / pharma industry with emphasis on biologic drug product formulation and process development, manufacturing, scale-up and technology transfer.
• Ideally strong knowledge and experience in development of formulations and processes for special protein deliveries as well as for highly concentrated protein formulations.
• Proven track record in resolving technical issues as well as strong track record in Innovation and Scientific topics.
• Highly structured and organized working style. Proven track record for working independently in development laboratory environment including knowledge HSE requirements for development laboratories. Good understanding of data integrity requirements in development environment.
• Solid understanding of quality principles in biologic drug product development. Experience in Good Manufacturing Practice (GMP) environment and/or GMP systems is an advantage.
• Interest and passion in data & digital topics, e.g. data analysis, data science, process modeling and automation. Strong knowledge in statistical data analysis and skills in data presentation.
• Basic knowledge in programming (e.g. Python, R) as well as basic knowledge and experience in process modeling (e.g. mixing processes) is an advantage.
• Interdisciplinary thinking and proven ability to work in cross-functional international teams.
• Strong presentation skills and scientific/technical writing skills.
• Good written and verbal communication skills.
• Proficient in English – spoken and written.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
 

Skills Desired