Cell Culture Scientist Jobs

Proclinical seeking a Cell Culture Scientist for a global biopharmaceutical company located in Wilmington, DE.
As the Cell Culture Scientist you will develop and optimize early and late phase bio-processes in support of our 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. This individual will be responsible for early and late phase cell culture process development which includes process development and optimization, manufacturing support, troubleshooting, process characterization, and validation.
Must be eligible to work in the US.
Job Responsibilities

• Author or review technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents and tech-transfer documents.
• 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.
• 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.
• Assist in technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
• 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.
• Executes experiments to support early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.

Skills And Requirements

• 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.
• Previous experience with authoring and/ or review of CMC sections for regulatory submission is beneficial but not necessary.
• 1- 5 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
• Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.
• 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.
• Ph.D. degree, Master's degree or Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biology, Molecular Biology, Biochemistry or Cell Biology.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or [email protected].
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.
INDSCIC