Associate Principal Scientist, Downstream Process Development

Job Description

Job Description In Primary Posting Language

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and implementation of new manufacturing technologies.

We work with our partners in the company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist. In this role, you will work with a highly collaborative team of Scientists and Engineers to design and develop downstream purification processes in support of early and late-stage biological products. The scope and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation, crystallization, and continuous processing for batch and intensified/continuous bioprocesses.

The role will also include strategic Applicants should have effective organizational and multi-tasking skills and strong communication skills both verbal and presentation of data is required. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientists, leading projects, and an external presence through scientific excellence are expected.

The successful candidate will contribute to CMC development of our company's pipeline, playing an active role in development of downstream processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies for process and pipeline-facing innovation.

• Leading biologic downstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable processes. Independently designing and conducting experiments using relevant operational parameters and analytical inputs.
• Providing technical supervision for process development and characterization
• Collaborate with upstream process development, Biologics Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance biologics pipeline.
• Advancing downstream platform process technical strategy, and championing creative process improvement initiatives
• Assessing new technologies, sciences, and industry strategies and relevance to our company
• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies
• Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies
• Mentoring junior scientists

• Ph.D. with 3+ years of industry experience or Master with 6+ years industry experience or BS with 8+ years in industry experience in Chemical Engineering, Biochemical engineering, or a related field

• Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.
• Scientific understanding of the engineering principles for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.
• Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.
• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors
• Knowledge of biologics CMC development cycle
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Experience with high throughput experimentation using automation platforms such as TECAN
• Experience using and/or programming process control systems such as DeltaV and PCS 7
• Experience with integrated and continuous processing and equipment including multi-column chromatography systems (BioSMB, PCC, or similar)
• Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine learning/artificial intelligence, leveraging PAT)

Artificial Intelligence (AI), Cell Line Development, Chemical Engineering, Chromatography, Clinical Supplies Management, Clinical Trials, Column Chromatography, Commercialization, Cross-Functional Collaboration, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors,…