Engineer II, Drug Substance Development
Other Locations:US- NJ- Summit West
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.
- Relied upon, front line member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient processes for active pharmaceutical compounds.
- Recommend and apply fundamental chemical engineering principles to solve challenges in process development from bench through to kilo-lab and/or pilot plant manufacture, on multiple projects in parallel.
- Develop scalable isolation processes for intermediates and active pharmaceutical ingredients, including control of salt, polymorph, particle size, and drying, while accounting for and communicating cross functional impacts.
- 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.
- Manufacture development candidates for use in pre-IND studies.
- Lead technical aspects of technology transfer to Contract Research/Manufacturing Organizations for production of GMP Drug Substance.
- Assist in the preparation of CMC regulatory documents.
- Remaining current with required GMP training and qualifications.
- Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
- Serve as a resource of scientific and technical expertise, while gaining cross functional and process development awareness.
- 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.
- Ph.D. with 2 years, M.S. with 5 years or B.S. with 10 years in Chemical Engineering or closely related discipline.
- Experience in pharmaceutical development as it relates to synthetic route selection, process development and optimization, pharmaceutical salt selection, polymorphism, solubility and stability testing.
- Experience with scale-up and technology transfer, moving from laboratory to pilot plant and production scale.
- Strong experience developing and executing 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 and ensure safe and effective process scale-up.
- Demonstrated proficiency in balancing resource requirements within 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, photomicroscopy, 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 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.
- Desire and demonstrated ability to mentor and teach others.
#LI-POSTCelgene 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.