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.
Director of QC - Biologics Development
15 years biopharmaceutical analytical experience with exposure to all stages of biologics development including QC operations
Analytical Development Biologics
Minimum of 15 years industrial experience in Biologics Development with increasing management responsibilities in analytical method development/QC preferred.
Ph.D. in relevant science field
This is a senior analytical role in Biologics Development/QC at Celgene. As a leader in the Analytical Development and QC team, the incumbent is responsible for building and managing a QC organization supporting clinical manufacturing. Transfer and validation of methods for measuring identity, purity, and degradation of large molecule therapeutics, from early to late stage - both from the internal Celgene pipeline and from third party collaborations will be required. This individual will be a key member of the Analytical Development leadership team and is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.
Responsibilities include, but are not limited to, the following:
Directs the overall scientific, technical and laboratory efforts of the QC function responsible for transfer and validation of analytical methods for large molecule drug substance and drug product, release and stability testing, and method transfers to other manufacturing sites.
Leads a high-performing team of QC scientists who are cross-functionally aligned with Biologics development and manufacturing team strategies and priorities to ensure timely release of product.
Ensures the delivery of high quality-related documentation to meet global regulatory expectations for analytical methods and controls. Delivers analytical source documentation for CMC sections of IND/CTA/BLA filings. Addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
Provides input to the development of project strategies, budgets, timelines, and product development plans. Helps ensure that scientific and business expectations are met.
Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities.
Is responsible for scheduling/coordination of laboratory testing, data review and approval of results within specified and negotiated timelines. Monitoring of laboratory metrics to provide senior management workflow and productivity information. Monitors lab supplies budget and recommendations for capital purchases.
Supervises laboratory analysts and technicians including performance evaluations/development, training on SOPs and approved test methods and hiring/promotion recommendations.
Authors/reviews SOPs and analytical test methods, method transfer protocols/reports and stability reports.
Responsible for initiating and execution of change control actions for lab- based testing requirements and test vendor process changes.
Responsible for routine interactions with contract laboratories to ensure successful method transfers and that routine testing in the contract lab is performed to the same standards as in the laboratory.
Leads OOS/aberrant investigations including writing/approving deviation/investigation reports and initiates/executes corrective/preventive actions.
Participates in safety committee meetings and ensures compliance with all laboratory regulations including cGMPs, DEA and OSHA regulations and SOPs.
Ensure laboratory readiness for and participate during regulatory inspections (FDA, EMA and DEA) and internal audits.
Complies with all Environmental Health and Safety Requirements.
Ph.D. in relevant scientific discipline required
15 years biopharmaceutical analytical experience with exposure to all stages of biologics development including QC operations preferred
Direct experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization, to support early and late stage product development and global commercial registration submissions
Solid understanding of how Biopharmaceutical Development integrates with key business partners
Proven leadership ability to align, motivate and empower team members
The ideal candidate will also have experience in interacting with CROs
Demonstrated ability for critical thinking, problem solving and innovation
Strong sense of value of investment and ability to develop cost-effective development plans
Effective communication, collaboration and negotiation
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment
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.