Celgene Engineering Fellow, Device Engineering - Drug Delivery Systems in Summit, New Jersey
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.
Engineering Fellow, Device Engineering - Drug Delivery SystemsSummit, NJ
Head of Device & Combination Product Development
PURPOSE AND SCOPE OF POSITION:
Reporting to the Head of Device & Combination Product Development, the Engineering Fellow is responsible for the design, development, and characterization of multiple drug delivery platforms including (but not limited to) prefilled syringes, auto/pen injectors and on-body injectors. This role requires innovative leadership of delivery system and combination product development programs supporting both the large and small molecule pipeline from new product development (NPD) through commercial lifecycle management (LCM). The Engineering Fellow, as the primary Device Design SME within Celgene, will provide input on strategic initiatives and goal setting across the development functions.
Additionally, the Engineering Fellow will be responsible for owning and implementing design control and ensuring collaborative partners and external suppliers are compliantly operating to the requirements of Celgene.This role will also be an integral member of compound development and biologic CMC teams from early development through technical commercialization and lifecycle optimization. The Engineering Fellow, in coordination with the Head of Device and Combination Product Development, will have an opportunity to build a diverse engineering team consisting of device engineers and development quality engineers.
Knowledge of primary containers, container closure systems, and drug delivery systems including reconstitution systems (closed and automated).
An understanding of end-to-end device and combination product design attributes including: packaging, sterilization, biocompatibility, drug-device compatibility and fill/finish.
Experience with clinical evaluation of drug delivery systems in all phases of the clinical development lifecycle.
Experience owning and managing DHFs from concept through commercialization.
Must be a technical/scientific expert with an ability to measure attributes in qualitative ways and drive science-based decisions across the organization.
Prior experience conducting device characterization studies/tests both in-house and via external partners including test method development.
Prior experience working with industry leading external manufacturing partners for finished devices, systems, and components.
Expert knowledge of the regulatory and compliance requirements for design controls and combination products (specifically, 21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, 93/42/EEC) with a special focus on human factors.
Must be skilled in strategic thinking, managing through influence, innovation management, and negotiation.
Must possess a global perspective and leadership disposition with a desire to work in a highly collaborative, cross-functional team environment
Must have strong mentorship and coaching skills focusing on the development of future organizational leaders.
Must be comfortable working in a dynamic and highly innovative environment.
DUTIES AND RESPONSIBILITIES
In conjunction with Small and Large Molecule Drug Product Development, shape the strategic direction of delivery systems through ownership and implementation of the device platform roadmap.
Sponsor and/or lead device and combination product development teams in coordination with Compound Leadership and BioCMC.
Ensure Celgene is pursuing novel technologies in targeted drug delivery areas via internal R&D and external partnerships including academia.
Collaborate with 3rd party partners (including external manufacturers, contract testing providers, and design firms) in the implementation and life-cycle management of platform technologies and innovative products.
Business owner for all aspects of Design Control for device and combination product development. This includes requirements flow-down (user requirements-design inputs-design outputs), vendor controls, verification, validation, and design transfer.
Serve as an SME related to Design Control and Device QMS within Celgene and during interactions with external vendors/third-parties.
Sponsor and or/lead device characterization studies from preliminary evaluation through design verification and human factor studies.
Own the physical characterization lab for combination products including capital budgeting and resourcing.
Partner with Commercial, Marketing, Clinical, Medical, and Technical Commercialization to create practical industrialization strategies and lifecycle management plans.
Actively participate in global industry associations and conferences, remaining current on emerging technologies, market trends and changing regulations.
Continuously develop and provide mobility for leaders within Celgene while ensuring a robust pipeline of talent and succession plan.
Ability to travel up to 25% globally.
EDUCATION AND EXPERIENCE
College or University degree required; advanced degree preferred. Degree focus areas include mechanical, biomedical and systems engineering, as well as, materials science. Minimum 12years relevant work experience, specifically in the design and characterization of delivery system technologies and/or medical devices and combination products. Minimum 5-7 years of leadership experience required.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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.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.