The pharmaceutical development group develops parenteral drug products by state of the art formulation and manufacturing 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, innovative 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 parenterals. The candidate will develop and justify manufacturing processes for biological and chemical products with a special emphasis on compounding, mixing and filtration. Furthermore, the candidate will design innovative experimental approaches to answer scientific questions to advance AbbVie's capabilities to process NBE drug products, including highly potent drugs. Working closely with analytical and formulation scientists in an integrated group the candidate will d evelop productive collaborations and communications with scientific development, clinical, and regulatory teams. The proactive development and alignment of business processes, also across departments and sites, will be a key responsibility. Major Responsibilities:
Self-motivated driving the process development of parenteral formulations for small molecules and biologics. Being the responsible process developer in connection with CMC and clinical teams to compile regulatory submissions. Driving the technology transfer from the laboratory scale to the pilot plant and commercial manufacturers. Designing experiments especially around compounding, mixing and filtration as critical process steps. 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. Proactive development of business practices and continuous improvement thereof, including feedback from relevant stakeholders on international level. Builds strong relationships to and drives activities with other functional units (e.g. pilot plant, combination products, drug-supply management). Mentors and develops others according to the AbbVie culture. Responsible for compliance with all applicable AbbVie policies and procedures. Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance. Level and compensation will be commensurate with experience.Basic:
BS (10+ years) or MS (8+ years) or PhD in Process Engineering, Chemical Engineering, Pharmaceutical Sciences, Biochemistry or related discipline with previous laboratory or technical experience required. Experienced in the process development of oral or parenteral drug products. Sound knowledge of regulatory requirements for the process development of new drugs. Preferred experience regarding compounding, mixing and sterile filtration. Preferred knowledge about influence of protein/surface interactions, e.g. for filtration or material compatibility studies. Experience in Microsoft Office (Excel, Sharepoint, PowerPoint, and Word) required. Statistical knowledge and experience e.g. capability analysis or design of experiments (DOE) methodologies. Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Associated topics: biochemistry, bioengineering, bioinformatic, biomedical, bioprocess, genetic, medical, molecular, neuroscience, therapeutic