Summit, New Jersey Req #: 1804383
Location: Summit, New Jersey, United States
Job Category: Biologics
Work Location: 556 Morris Avenue 07901
Employee Status: Full-time
Job Type: Regular
The Scientist will work within the Biologics Drug Product Development organization to lead drug product process and primary packaging development activities and be responsible for tech transfer to the clinical and commercial DP manufacturing sites for the early and late stage therapeutic protein products. The Scientist will also work as a Drug Product Development Team Lead in a larger CMC team for one or more assets.
- Design and execute experiments to develop robust manufacturing processes and primary container configurations (including combination products) to be transferred to CMOs for biologic products at different stages of development up to commercialization as well as life-cycle management.
- Champion and influence development of drug product process expertise in the organization. Enable generation of high quality data based on sound scientific principles and summarize the results in internal/external scientific/regulatory publications/filing.
- Champion set-up of the biologics process development labs to support and implement state-of-the-art technologies, including the use of innovative and scale-down approaches to design robust manufacturing processes.
- Lead or participate in drug product development teams and be responsible for the planning and execution of product development plans including all aspects of drug product process development, formulation, technology transfer, scale-up, and validation activities.
- Support CMO investigations, provide technical support to manufacturing, and interact with internal and external customers and stakeholders to drive project milestones.
- Maintain currency with applicable global regulations and industry standards for formulation and drug product development for recombinant therapeutic proteins.
- Maintain and enforce safe laboratory practices and environment.
- Interact effectively with members of the Biologics Development department, and with other Celgene stakeholders (Quality, Regulatory CMC, Global Manufacturing, Project Leadership, Commercial, and Clinical organizations).
Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or relevant scientific discipline with 10+ yrs of relevant industrial experience in drug product process development of therapeutic protein products. MSc with >15 years and BSc with > 20 years of relevant industrial experience will also be considered.
- Strong scientific background and hands-on experience in biologics drug product process development for liquid and lyophilized products.
- Demonstrated experience to work independently and conduct experiments to evaluate and establish robust process conditions for product manufacturing in the context of formulation and drug product target profile.
- Technical expertise in aspects of drug product unit operations, including bulk storage, freeze/thawing, compounding, mixing, sterile filtration, filling, lyophilization, and formulation as well as primary packaging.
- A thorough understanding of the relationships between process, formulation, and device design for the performance, quality, and stability of biological drug products.
- Experience in multiple approaches for experimental design and statistical data analysis including Design of Experiments (DoE) and computational modeling tools (e.g. CFD) for process development and scale-up.
- Working knowledge of current US, EU, and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing.
- Understanding and experience with GMP manufacturing and compliance preferred.
- Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
- Strong project and time management skills are essential.
- Demonstrated ability for critical thinking, problem solving and innovation.
- Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
Location : Summit, NJ
Travel : , <10% of the time
About UsCOMMITTED 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.