Proclinical is currently recruiting for a Research Scientist of Biologics Cell Culture Process Development for a pharmaceutical company located in Wilmington, DE. Successful candidate will develop and optimize early and late phase bio-processes in support of the company's biologics pipeline that includes monoclonal or bispecific antibodies, fusion proteins, and other large molecules in early to late stage clinical development as well as commercial launch.
- Executes experiments to support early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.
- Assist in technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
- Serves as a person-in-plant during key manufacturing/ development activities in a contract manufacturing/ research facility to drive development of pipeline molecules leading to commercialization.
- Author or review technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents and tech-transfer documents.
- Collaborates closely with cross-functional teams like purification, analytical and formulation, as well as QA and regulatory, to support batch release, manufacturing investigations, and risk analysis.
- Make presentations as necessary to internal functions and external partners as a part of development and commercialization of pipeline molecules.
- Takes leadership in promoting technology development and continuous improvement to streamline biologics development.
- Communicates clearly and collaborate actively with internal cross-functional teams to facilitate pipeline development of large molecules.
Skills and Requirements:
- Ph.D. degree, Master's degree or Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biology, Molecular Biology, Biochemistry or Cell Biology.
- 1- 5 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
- Hands-on experience with cell culture process development, manufacturing support or GMP manufacturing, troubleshooting, authoring and review of batch record is essential.
- Previous experience of working on several projects running simultaneously while working independently as well part of a team is essential.
- Experience with cell line development, scale-up, technology transfer, design of experiments, bioreactor culture, bioprocess automation, process characterization, validation and process risk analysis is preferable.
- Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.
- Previous experience with authoring and/ or review of CMC sections for regulatory submission is beneficial but not necessary.
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.
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