Research Investigator, Cell Culture Process Scienc
Click the Facebook, Google+ or LinkedIn icons to share this job with your friends or contacts. Click the Twitter icon to tweet this job to your followers. Click the link button to view the URL of the job, which then can be copied and pasted into an e-mail or other document.
Wilmington, DE 19803
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function):
The cell culture scientist will lead the development and optimization of early and late phase bio-processes in support of Incyte’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. The 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. As necessary, he/ she will be required to work with Incyte GMP manufacturing group or a CMO/ CRO for process execution, troubleshooting, batch record reviews, reports, process risk analysis, and manufacturing investigations. The individual may be needed to be a person-in-plant to assist in successful process transfer and/ or management of CMO/ CRO activities for pipeline molecules. The individual will work directly with Incyte CMC and process teams, which includes project management, purification, analytical, and formulation. On occasions, he/she may be needed to assist quality assurance and regulatory team members. The individual is expected to multi-task on several projects running simultaneously.
Keywords: upstream, cell culture, process development, bioreactor, process characterization, design of experiments
Essential Functions of the Job (Key responsibilities):
- Execute early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.
- Lead 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 technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents, CMC sections of regulatory document and tech-transfer documents.
- Collaborate 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.
- Take leadership in promoting technology development and continuous improvement to streamline biologics development.
Qualifications (Minimal acceptable level of education, work experience, and competency):
- Ph.D. degree or Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry or Cell Biology.
- Ph.D. degree with 3-5 years of experience or Master’s degree with 5-8 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
- Experience with cell culture process development, technology development, troubleshooting, authoring and review of batch record is essential.
- 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.
- Experience with authoring and/ or review of CMC sections for regulatory submission is preferred.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact firstname.lastname@example.org if you have any questions or concerns or would like to exercise your rights.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.