Research Investigator, Drug Product Technologies
Proclinical is currently recruiting for a Research Investigator, Drug Product Technologies for a pharmaceutical company located in Wilmington, DE. Successful candidate will work within CMC Biologics Formulation and Drug Product Development organization and will research and develop viable formulation to support preclinical and clinical studies and robust and scalable manufacturing processes for monoclonal antibodies biologic products.
- Design and conduct experiments to develop formulations, manufacturing processes for biologic products 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 by working closely with the drug product project lead and development team.
- Will 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 Biologics Development department, and cross-functional internal and external partners.
- Will participate regulatory submission
Skills and Requirements:
- PhD in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 2 yrs of relevant industrial experience in formulation and drug product development of therapeutic protein products. MS/BS with a minimum of 5 years of relevant industrial experience will also be considered.
- Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
- Demonstrated experience in conducting experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
- Technical expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
- Basic understanding of 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).
- Understanding and experience with GMP manufacturing and compliance preferred.
- 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 in the laboratory.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.