Req #: 1804201
Location: Summit, New Jersey, United States
Job Category: Biologics
Work Location: 556 Morris Avenue 07901
Employee Status: Full-time
Job Type: Regular
Scientist I – Upstream Process Development
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Associate Director , Upstream Process Development
Biologics Development and Manufacturing
Ph.D. in Chemical Engineering, Biological Sciences, or relevant disciplines, with minimum 1 year of relevant industrial experience or MS with minimum of 7 years relevant industrial experience or BS with minimum of 10 years relevant industrial experience
This Scientist I position will be responsible for the development, scale-up and tech transfer of robust upstream processes for production of recombinant proteins. The successful applicant will be expected to work with minimal supervision, provide strong technical leadership and play a critical role in cross-functional collaborations with internal and external partners.
Responsibilities will include, but are not limited to, the following :
Developing high-performance upstream production processes in a timely manner, especially for novel protein therapeutics such as bispecific antibodies.
Using sound scientific and engineering principles to improve robustness of existing processes utilizing various bioreactor configurations and process formats.
Collaborating closely with Cell Line Development (CLD) and Downstream Process Development (DSP) groups to improve workflow efficiency and overall process yield while maintaining product quality considerations.
Leading tech transfer activities to internal Clinical manufacturing operations as well as external CMOs for process scale-up including performing risk assessment and developing appropriate mitigation strategies. Provide PIP support for manufacturing activities and troubleshooting efforts when needed.
Participating as a DS representative in cross-functional CMC teams to plan project timelines and meet material supply requirements such as pilot scale Tox run.
Supporting new technology assessment including external collaborations for improved process understanding. Developing appropriate IP strategies to ensure FTO and to create and strengthen our patent estate in the field.
Writing technical summary and development reports for efficient knowledge management and regulatory filing support.
Publishing or presenting scientific findings in peer-reviewed journals or conferences and contributing to industrial collaborations.
Providing supervision and mentorship to junior scientists or associates.
Skills/Knowledge Required :
Proven track record of accomplishments in the design, development, and implementation of industrial cell culture processes for recombinant protein production.
Hands-on experience with upstream laboratory activities including the operation of high throughput mini-bioreactors as well as pilot scale single-use bioreactor systems.
Knowledge of bioreactor characterization and engineering principles as well as robust understanding of biochemistry and cell metabolic pathways is a must. Media development experience is a plus.
Demonstrated experience with technology transfer and scale-up to GMP manufacturing facility including providing PIP and trouble-shooting support.
Late-stage process development activities including process characterization and control strategy.
Familiar with CMC timelines and cross-functional collaborations including CLD, DSP, Analytical development, Manufacturing, MS&T, Regulatory among others.
Demonstrated ability to evaluate and introduce new technologies to accelerate upstream process development and improve process efficiency.
Strong project leadership and excellent resource management skills.
Excellent verbal and written communication skills.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.