Celgene Scientist II, Upstream Process Development in Summit, New Jersey
This Sr. Scientist position in Biologics Upstream Process Development will focus initially on a bispecific program, and be responsible for the development of scalable cell culture processes, for research and Tox material production, and for scale up and transfer of processes to GMP facilities for clinical manufacturing, towards IND submission by the year end of 2017.
Responsibilities will include, but are not limited to, the following:
1.Developing highly productive upstream processes in a timely manner for novel protein therapeutics such as bispecific antibodies.
2.Using sound scientific and engineering principles to design robust and scalable upstream processes, in consideration of various bioreactor configurations and process formats.
3.Collaborating closely with Cell Line Development (CLD) and Downstream Process Development (DSP) groups to improve workflow efficiency and overall process yield.
4.Leading tech transfer to CMOs for process scale-up and GMP manufacturing including risk assessment and mitigation strategy development. Perform PIP for production support and troubleshooting.
5.Participating in cross-functional collaborations to meet project timelines and material supply requirements.
6.Understanding the IP landscape around subject technologies, and developing IP strategies to ensure FTO and to create and strengthen the patent estate in the field
7.Writing technical summary and development reports for efficient knowledge management and regulatory filing support
8.Publishing or presenting scientific findings in peer-reviewed journals or conferences, and contributing to industrial collaborations
9.Providing supervision and guidance to junior scientists or associates
Ph.D. in chemical engineering, biological sciences, or relevant disciplines, with 6-8 years industrial experience in mammalian cell culture for the production of recombinant protein therapeutics
Ph.D. in chemical engineering, biochemistry, or appropriate technical disciplines
6-8 + years industrial bioprocess experience with a proven track record of accomplishments in the design, development, and implementation of bioreactor cell culture processes including trouble-shooting and decision making
Hands-on experience with upstream development laboratory activities. Knowledge of upstream process equipment at development and pilot scales
Proven technology transfer and scale-up experience.
Demonstrated ability to simultaneously manage multiple projects, and to function in a collaborative/team oriented environment.
Ability to introduce new technologies to accelerate upstream process development and improve process efficiency
Good verbal and written communication skills.
Strong project leadership and resource management skills.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Scientist II, Upstream Process Development
Location: Summit, NJ, US
Job ID: 17000206