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.
DUTIES AND RESPONSIBILITIES
1) Perform Development Batch Record Review Function: Conducts batch record review of development batches of drug substance, drug product and package/labeling jobs with particular emphasis on experience with reviewing Biologics including Cell Drug Batch Records. Provides input on clinical product disposition. Establishes positive relationships and interfaces with contract manufacturers and testing laboratories to communicate and promptly resolve quality issues. May represent QA on assigned project and development product teams. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
2) Perform Document Review Function: (and may approve as required) SOPs, qualification and validation documents, technology transfer documents, analytical data and CMC sections prior to submission to regulatory bodies. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
3) Compliance Systems: Implements and maintains the activities for development batch record review, SOP review, contractor management, qualification/validation review, and technology transfer, in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and project timeline expectations.
4) Vendor Contacts: Communicates as required, with outsourced manufacturing, packaging/labeling and/or testing service providers regarding quality assurance issues noted during reviews.
5) Communications: Proactively communicates, works with and provides timely services to staff and internal colleagues in QA, QC, AR&D, Investigational Materials Supply Chain (IMSC), Information Systems, Metrology, Facilities and Training groups.
6) Human Resources: Ability to function in a fast paced environment and anticipate/adapt to changing needs and priorities. Consistently meets performance objectives. May be asked to assist in the evaluation of prospective employees for the quality assurance department.
EDUCATION AND EXPERIENCE
Minimum of a Bachelor’s degree in a relevant scientific discipline.
3 plus years of hands on CMC experience within a development/operations facility for Biologics. Experience with Cell Drug products will be a definite advantage. Periods spent within the Quality organization at a Production Center is desirable.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
§ BS/MS in a relevant scientific discipline.
§ 3 plus years of experience within QA functions in pharmaceutical industry
§ Thorough knowledge of cGMP in the pharma/Biotech industry. Good understanding of drug development process.
§ Knowledge and application experience with batch record review with particularly strong emphasis on Biologics, especially Cell Drug Batch Records, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer.
§ Partner with early and late stage Biologics development teams to identify and qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical product.
§ Partners with Quality Ops to ensure Quality Agreements are in place for Clinical Supply.
§ Responsible for change control management through the development process to include impact assessments, tracking and implementation.
§ Must have strong interpersonal and communication skills, be a team player
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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.