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.
Additional Salary Information: Celgene offers a total compensation package that is highly competitive in the biopharmaceutical industry.
Celgene CorporationDriven by PASSION FOR THE PATIENT.
-Preeminent Global Biopharmaceutical Company- ~7,500 Employees Worldwide- Operations in >60 countries and sales in >70 countries.
-Focused on Discovery, Development and Commercialization of Innovative Therapies for Unmet Medical Needs in Cancer and Immune-Inflammatory Diseases.
- 8 marketed products (hematology, oncology and immunology)-... Focused on R&D; >30 Phase III programs underway and 300+ clinical trials
- Diverse technology platforms and commitment to sustaining innovation