Job Summary (Primary function)
The Principal Research Investigator will work within Global Biopharmaceutical Development, Drug Product Technology organization and will research and develop viable formulations and robust and scalable manufacturing processes for monoclonal antibodies and bispecific biologic products to support preclinical, clinical studies and commercial use.
Essential Functions of the Job (Key responsibilities)
- The successful candidate will conduct objective research to develop formulations, manufacturing processes, primary container configurations for biologic products and combination product at different stages of development.
- Will participate in drug product development teams and contribute to the planning and execution of product development studies including all aspects of formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
- Will design, execute, and interpret development studies based on defined project objectives.
- Will manage CRO and CMO to generate high quality data based on sound scientific principles and summarize the results in technical reports, scientific papers, presentations, and regulatory documents.
- Will interact effectively with members of the Global Biopharmaceutical Development department, and cross-functional internal and external partners.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D/MSc/BS in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 8 years of relevant industrial experience in formulation and drug product development of therapeutic protein products.
- Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
- Experience in develop the optimal formulations for biological products and establish robust process conditions for manufacturing.
- Technical expertise in aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
- Understanding the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
- Experience in statistical experimental design and data analysis including Design of Experiments (DoE).
- Experience with Process characterization, validation, risk assessment and control strategies of Protein Drug Product.
- Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
- Demonstrated ability for critical thinking, problem solving and creativity.
- Strong organizational and planning skills.
- Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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