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Principal Engineer Integrated Materials Engineering and Technology

Company: Celgene
Location: Summit
Posted on: June 15, 2019

Job Description:

Principal Engineer Integrated Materials Engineering and Technology Req #: Location: Summit, New Jersey, United StatesJob Category: Technical DevelopmentWork Location: 556 Morris Avenue 07901Organization: Drug Product DevelopmentEmployee Status: Full-timeJob Type: Regular Principal Engineer Integrated Materials Engineering and Technology Summit, NJCelgene 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.This position is responsible for establishing Process Analytical Technology (PAT) methods for process development, characterization, optimization, scale-up, and technology transfer activities of small molecule for clinical development of new pharmaceutical products.Responsibilities will include, but are not limited to, the following:Key member of a dynamic scientifically driven team dedicated to the development and optimization of robust manufacturing processes for drug products.Apply material profiling, process analytical expertise and statistical methods to evaluate the composition, structure, and properties of pharmaceutical systems. Perform data analysis and interpretation (e.g., multivariate analysis, chemometrics, etc).Lead PAT method development, validation, transfer and implementation.Work with product and process development teams to provide critical data needed to commercialize new technologies, optimize or enhance existing products or processes.Lead the identification, development, and deployment of new PAT instrumentation, technologies, and methodologies to support efficient and effective drug product process development, process characterization, understanding and improvement.Serve and represent the team on multidisciplinary CMC teams.Responsible for the design and execution of complex experiments to characterize drug product manufacturing processes utilizing various PAT technologies.Ensure fundamental engineering principles are applied to characterize and solve process challenges across multiple unit operations, utilizing both experimental, PAT and process simulation/modeling approaches.Prepare technical reports, publications and oral presentations and contribute to the preparation of CMC regulatory documents.Provide technical consultation as needed to product technology, CMC, manufacturing, and commercial teams to support new growth programs and production optimization efforts.Coach and develop scientists/engineers under a project specific matrix team.Assume departmental responsibilities for assigned projects and equipment.Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.QualificationsPrerequisite:Ph.D. in Chemical/Biochemical Engineering, Pharmaceutical Science, Material Science, Analytical Chemistry or related fields with minimum 8 years experience in engineering or related field; M.S. with minimum of 10 years experience in engineering or related field; or, B.S. with minimum of 12 years in engineering or related field.Skills/Knowledge Required:Strong background in PAT, chemometrics and pharmaceutical development as it relates to formulation development and process development/optimization. Hands-on technical expertise with effective instrument operation and maintenance, and strong theoretical understanding in one or more of the following fields is required:Spectroscopy (FTIR, NIR, Raman) with chemometric data analysis.Material / Pharmaceutical/ Separation ScienceProcess Analytical TechnologyStatistical data analysis and multivariate data analysisProgramming experience with MATLAB, S-PLUS, SAS and familiarity with commercially available chemometric packages such as SIMCA-P, Unscrambler and GramsExperience across various solid oral dosage conventional and enabling manufacturing technologies.Demonstrated capability orchestrating development and execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative PAT solutions to overcome process development obstacles.Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.Knowledge of cGMPs during pharmaceutical development and clinical/commercial manufacturing.Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or in leading a team under deadline. Strong verbal and written communication skills are essential.Ability to supervise, coach, and mentor junior-level engineers.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.#LI-POSTAbout UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt 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. Associated topics: ceramic, corrosion, dental, glass, metallic, metallographer, metallurgical, plastics, polyurethane, welding

Keywords: Celgene, New York , Principal Engineer Integrated Materials Engineering and Technology, IT / Software / Systems , Summit, New York

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