Senior Engineer, Drug Substance Development

Employer
Celgene
Location
Summit, NJ, US
Posted
Sep 14, 2018
Ref
1803142
Required Education
Doctorate/PHD/MD
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

Responsibilities include:
  • Key member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical processes for active pharmaceutical compounds.
  • Serve as Drug Substance Development representative on multidisciplinary CMC teams.
  • Apply fundamental chemical engineering principles to solve challenges in process development from bench through to kilo-lab and/or pilot plant manufacture.
  • Develop scalable isolation processes for intermediates and active pharmaceutical ingredients, including control of salt, polymorph, particle size, and drying.
  • Apply fundamental chemistry and engineering principles to characterize and solve process challenges across multiple unit operations, including reaction kinetics, heat/mass transfer, fluid mixing, multiphase reactions and systems, and process safety, utilizing both experimental and process simulation/modeling approaches.
  • Lead the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug substance process development.
  • Manufacture development candidates for use in pre-IND studies.
  • Remaining current with required GMP training and qualifications.
  • Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
  • Manage technology transfer to Contract Research/Manufacturing Organizations for GMP Drug Substance.
  • Assist in the preparation of CMC regulatory documents.
  • Serve as a resource of scientific and technical expertise.
  • Supervise 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.
  • Prepare technical reports, publications and oral presentations.


Skills/Knowledge Required:
  • Ph.D. + 5 years, M.S. +10 years in Chemical Engineering.
  • Experience in pharmaceutical development as it relates to synthetic route selection, process development and optimization, pharmaceutical salt selection, polymorphism, solubility and stability testing.
  • Experience leading scale-up and technology transfer, moving from laboratory to pilot plant and production scale.
  • 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 solutions to overcome process development obstacles.
  • Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.
  • Excellent laboratory skills and knowledge in application on organic synthesis. Proficient in the use and interpretation of modern analytical techniques, e.g. DSC, TGA, XRD, Phototmicroscopy, particle size measurement techniques, Reaction Calorimetry, NMR, HPLC, and process automation platforms.
  • 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. Verbal and written communication skills are essential.
  • Experience with broad CMC issues encountered in drug development is highly desirable. Familiarity with the application of cGMP during pharmaceutical development and production, and experience with regulatory filing (IND/NDA) a plus.
  • Direct or indirect supervisory experience.


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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.