Senior Scientist Process Development, New Biological Entities Development
The pharmaceutical development group develops parenteral drug products by state of the art formulation, processing and analytical technologies. We drive the development of new biological and chemical entities, with a special emphasis on antibody drug conjugates. Our focus is to advance AbbVie's pipeline by creating intellectual property through new formulation compositions, lean and smart manufacturing processes and we prepare CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person who independently drives process development activities for NBEs. The candidate will develop, scale-up and justify manufacturing processes for biological and chemical parenteral products and represent Process Development in a CMC environment. Furthermore, the candidate will design innovative experimental approaches to answer scientific questions to develop and optimize drug product manufacturing processes, including scale-down, simulation and modelling approaches. Working closely with analytical and formulation scientists in an integrated group the candidate will develop productive collaborations and communications with scientific and regulatory teams. The proactive development and alignment of business processes, also across departments and sites, will be a key responsibility.
Key Responsibilities Include:
- Proactively drive the process development of parenteral formulations with a focus on antibody drug conjugates.
- Independently develop scale-up and scale-down strategies and models for parenteral manufacturing processes e.g. from bench to pilot-plant scale or to external partners.
- Being the project lead process developer within a joined CMC team, including responsibility for process design and authoring of scientific as well as regulatory documents and patents.
- Independently plan, perform and document scientific experiments and extract as well as communicate relevant findings in reports and presentations.
- Make concise scientific presentations and publications within and outside AbbVie including conferences.
- Drive development of business practices and continuous improvement thereof, including feedback from relevant stakeholders on international level.
- Builds strong relationships to other functional units and drives activities in collaboration with partners like TPMs.
- Mentor and develop others according to the AbbVie culture including post-docs.
- Responsible for compliance with all applicable AbbVie policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
- BS (10+ years) or MS (8+ years) or PhD (1+ years) in Process Engineering, Chemical Engineering, Pharmaceutical Sciences or related discipline with previous laboratory or technical experience.
- Experienced in process development of biological entities, from compounding, mixing, filtration and lyophilization to fill & finish.
- Sound knowledge of regulatory requirements for the process development of NBEs and parenteral NCEs.
- Experience in Microsoft Office (Excel, Sharepoint, PowerPoint, and Word) required.
- Statistical knowledge and experience e.g. capability analysis or design of experiments (DOE) methodologies.
Key AbbVie Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.