Research Investigator/ Sr. Research Investigator, Large Molecule Cell Culture Development
Incyte Corporation is seeking an experienced cell culture scientist to provide technical expertise in manufacturing process development and optimization primarily through contract manufacturing/ research organizations (CMOs/ CROs) for new therapeutic biological products including monoclonal antibodies, fusion proteins, and antibody-drug conjugates in early to late stage clinical development as well as commercial launch. The individual will be responsible for early and late phase cell culture CMC development which includes cell line development, early and late stage process development/ optimization, GMP clinical manufacturing, troubleshooting, process characterization, validation and regulatory submission. He/ she will be responsible for working with CMO/ CRO for study design and execution, batch record reviews, reports, process risk analysis, manufacturing investigations, and regulatory submissions. The individual will be needed to be a person-in-plant to ensure management of CMO/ CRO activities of pipeline molecules. The individual will work directly with Incyte Quality Assurance and Regulatory team members as well as CMC team, which includes purification, analytical and formulation. The individual is expected to multi-task on several projects running simultaneously.
Responsibilities and Job Duties
- Support cell line development, early and late-stage cell culture process development, scale up, technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
- Serve 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 cell line and cell culture development and manufacturing CMC sections for regulatory submissions, technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents and tech-transfer documents.
- Support late-stage process development, characterization and validation activities towards commercialization of pipeline molecules.
- Assist in technology transfer of developed cell culture processes to internal and external GMP manufacturing sites.
- Collaborate closely with cross-functional teams like QA, regulatory, purification, analytical and formulation teams to support batch release, manufacturing investigations, operational planning and risk analysis.
- Make presentations as necessary to internal functions and external partners as a part of development and commercialization of pipeline molecules.
- Serve as subject matter expert for cell line development and/ or cell culture process development and manufacturing. Take leadership in promoting technology development and continuous improvement to streamline biologics development in Incyte.
- Communicate clearly and collaborate actively with internal cross-functional teams and external CMOs to facilitate pipeline development of large molecules.
- Ph.D. degree or Master’s degree or Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biology, Molecular Biology, Biochemistry or Cell Biology with at least 2 years or 4 years or 6 years of hands-on experience respectively working in cell line development and/ or cell culture process development/ manufacturing in a biopharmaceutical industry.
- Hands-on experience with cell line development, and/ or cell culture 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, cell culture process development, scale-up, technology transfer, design of experiments, bioprocess automation, process characterization, validation and process risk analysis is preferable.
- Hands-on experience in GMP cell culture manufacturing operations and/ or management of CMO operations in a similar capacity as a person-in-plant is preferable.
- Experience with authoring and review of CMC sections for regulatory submission is preferable.
- Experience with submission process for regulatory agencies and ICH guidelines are preferable.