Celgene Sr. Manager, Analytical Tech Services 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.
Responsible for managing an Analytical Tech Service group that provides analytical support to Celgene marketed products and the corresponding commercial active pharmaceutical ingredients (APIs). The position involves problem solving of non-routine commercial laboratory issues/investigations, supporting of continuous commercial process improvement, response to health authority questions, analytical oversight of commercial contract testing laboratories, and managing counterfeit investigations. The position holder is expected to exhibit technical prowess and capability in both API and drug product analytics. The position holder is also expected to be familiar with drug development/tech transfer process, compendia requirements, ICH and regulatory guidelines.
Responsibilities will include, but are not limited to, the following:
Leads and manages the laboratory activities associated with commercial products method troubleshooting and remediation.
Supervises qualification and method transfer activities (internal and external) to commercial testing sites.
Leads OOS/OOT investigations including writing/approving deviation/investigation reports and initiates/executes corrective/preventive actions.
Leads and manages counterfeit samples testing and investigation.
Manages analytical testing using a variety of analytical techniques such as HPLC/UPLC, Dissolution, Karl Fischer, UV/Vis, GC, FTIR, LC/MS, PSD, SEM, etc.
Understands the relevant scientific and technical principles required for analytical functions for the analytical instruments and methodology used.
Draws conclusions from data and results and communicates/reports to management and cross-functional project teams.
Recognizes unexpected outcome/problems; proposes solutions; communicates and works to solve problems.
Manages reference standards qualification and requalification program.
Manage laboratory, test methods and specifications related change controls and CAPAs.
Support commercial sites on health authority inspections.
Support pharmacopeia periodic review and monograph preparation for Celgene commercial products.
Partners with various departments (Commercial Manufacturing Organization (internal and external), Quality Control and Quality Assurance , Analytical Development, Commercial Technical Services (API and drug product), RegCMC and Supply Chain).
Follows GLP and cGMP principles, internal standard operating procedures (SOPs), and regulatory requirements.
10+ years of experience in Quality Control/Compliance/Analytical Research & Development with at least 5 years laboratory management experience; MS/PhD Chemistry or relevant discipline.
Strong oral communication/presentation, writing/documentation, and interpersonal skills.
Strong decision making & problem solving capability. Technically adept and logic-based decision process.
Demonstrated management skills including leadership, time management, work allocation/delegation and prioritization.
Experienced with drug development and tech transfer process.
Familiar with compendia requirements, ICH and regulatory guidelines.
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.
Sr. Manager, Analytical Tech Services
Location: Summit, NJ, US
Job ID: 17001509