Celgene Manager, Technical Services - Drug Substance Development 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.
Responsibilities include, but are not limited to:
Serve as a key member of a dynamic, scientifically driven team dedicated to the development, optimization, and commercial implementation of safe, scalable, and efficient chemical processes for active pharmaceutical compounds.
Lead and manage technology transfer of synthesis processes to commercial sites and facilities for production of GMP drug substance and intermediates (both internal facilities and external/CMOs)
Evaluate supply site capabilities vs. process and project requirements to develop site-selection recommendations.
Oversee process knowledge transfer to commercial sites, site/process risk assessments, and site process characterization activities. Apply fundamental chemistry and chemical engineering principles to solve challenges in process scale-up and robust performance of unit operations at commercial scale.
Manage site preparation and execution of process demonstration and process validation campaigns including review and approval of process equipment setups and batch records, and oversight of process execution.
Support site preparation/readiness and execution of pre-approval inspection (PAI) and other health authority inspections.
- Support commercial products and processes
Review and assess process deviations and customer complaints. Assist in development and implementation of corrective and preventative actions (CAPA), and management of process change controls.
Evaluate ongoing process performance and support continuous process verification (CPV) and assessment of process improvement opportunities.
Serve as the Drug Substance Development representative on multidisciplinary CMC teams.
Assist in the preparation of CMC regulatory submissions and supporting documents.
Serve as a resource of scientific and technical expertise. Assume departmental responsibilities for assigned projects and technology platforms.
Supervise other scientists/engineers under a project specific matrix team.
Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals and the work of the DSD department.
Prepare technical reports, publications and oral presentations.
Skills/Knowledge Required :
Ph.D. + 5 years, B.S./M.S. +10 years in Chemical Engineering or Process Chemistry.
Experience in process development, technology transfer, and manufacturing related to small molecule drug substances. Familiarity with the application of cGMP regulations and principles, and experience with registration dossier filings (NDA, MAA).
Experience with cGMP compliance, quality systems and audits, and regulatory inspections.
Demonstrated capability in project organization and management, including managing 3rd party activities. Capability in process risk assessment, and development and execution of experimental work to address process robustness, productivity, and cost. Demonstrated proficiency in the interpretation of analytical and physical property data.
Demonstrated record of implementing creative, efficient, and effective solutions to overcome project obstacles, integrating efforts with specialists from other functional disciplines. Experience with cross-functional CMC issues encountered at the drug-substance/drug-product interface during development and scale-up is highly desirable.
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.
Direct or indirect supervisory experience.
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.
Manager, Technical Services - Drug Substance Development
Location: Summit, NJ, US
Job ID: 17001512