Senior Scientist I (Downstream Process Development)

GRIFOLS, S.A.

2d•$130,000 - $170,000

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. GigaGen, a subsidiary of Grifols, discovers and develops next-generation recombinant antibody therapeutics. Our core technology utilizes a microfluidic droplet system to capture and immortalize diverse immune repertoires, which can then be mined for exceptional monoclonals or enriched and used as high-potency polyclonal therapeutics. Our preclinical and clinical pipeline includes several recombinant polyclonal products for infectious diseases and a monoclonal antibody with a unique mechanism for oncology. We are seeking a Senior Scientist I to lead our downstream process development and technology transfer efforts for our diverse recombinant monoclonal and polyclonal antibody therapeutics pipeline. The Process Development team at GigaGen consists of a small group working closely together on upstream, downstream, and analytical method development, with the opportunity to contribute critical results to early-stage and clinical-stage products.

Requirements

Bachelor with 8+ years of experience or Master with 5+ years of experience or PhD. with 3+ years of experience
Significant technical expertise in antibody purification, including use of multiple types of chromatography and filtration
Ability to work independently to troubleshoot processes and develop new methods
Experience in oversight of technology transfer to CDMOs
Exceptional communication and interpersonal skills to establish positive relationships with internal stakeholders, CROs/CDMOs, and multi-functional/multi-cultural teams
Accuracy and attention to detail
Proactively introduce new methods, provide technical mentorship to colleagues, and identify and execute ways to keep the lab running efficiently

Responsibilities

Stay abreast of technical advancements in the CMC area of downstream process development for biologics
Design and execution of experiments to establish purification processes for novel polyclonal antibody products. This includes proposing and running experiments or supervising execution of experiments, and reviewing and analyzing data
Communication with the upstream process development and analytical teams and technical leadership regarding downstream tasks for routine protein production
Optimization and scale-up of processes in preparation for transfer to manufacturing
Lead and support various elements of early-stage CMC development activities, including technical support of non-GMP and clinical manufacturing, as well as development and implementation of process improvements, as programs advance through development
Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work, including review and approval of batch records, data, and reports
Authoring of specific process development and manufacturing sections (CMC/Quality modules) for global regulatory submissions
Data analysis, interpretation, and effective communication to management