Director QA, Biologics Development
Other Locations:US- NJ- Summit West
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.
The Position develops the Quality Strategy for New Biologics Development Compounds for both Drug Substance and Drug Product, including testing and stability strategies. The incumbent will cover multiple CMC Biologics Development teams and will report to the Executive Director of New Product Development, Global Quality Assurance. He/she will be expected to supervise and lead an integrated Biologics QA development team within the Global Quality Operations, Development function.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful BLA/NDA approval.
- Knowledge of multiple pharmaceutical dosage forms (Solid, Parenterals/Biologics, etc) would be considered an advantage (including Drug Substance manufacturing).
- Good understanding of the GMPs as related to Pharmaceutical Development.
- Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies.
- Track record of successful Pre-Approval Inspections.
- Proven application of QBD development skills.
- Good Knowledge of CMC Regulatory Affairs for both development and marketed products.
- Recognized as a CMC expert with an ability to introduce best practices into the CMC Development Process
- Strategic Thinking and Influencing
- Promoting open communication (Exceptional communicator who is able to work with all levels of the organization)
- Cross-functional collaboration
DUTIES AND RESPONSIBILITIES
- Member of CMC Development Teams providing Quality input from Phase 1 through Development to Product commercialization.
- Partners with the Biologics Development function to develop and approve the Pharmaceutical Development strategy for new drug candidates.
- Partner with the Biologics Development function to identify and qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical and Commercial product. (Drug Substance and Drug Product). Key member of the Quality Audit Team / partners with Quality Operations to ensure Quality Agreements in place for Clinical Supply. This may require about 15% of domestic and international travel.
- Responsible for change control through the development process to include impact assessments, tracking and implementation to ensure a compliant fileable product and process is developed
- Track/Own ongoing regulatory updates to Health Authorities (e.g. IND/BLA) from a quality perspective including specifications, shelf life extensions, country specific trial approvals etc.
- Work with CMC Teams to conduct risk assessments for all aspects of the Development Process and Supply chain as well as for the future commercial supply chain.
- Final Quality approver for all GMP documentation associated with the Development and Validation of the Product to include Manufacturing and Testing Methods, Specifications, Experimental and Validation Protocols and Reports.
- Responsible for the Quality input to the CMC sections of the IND/BLA and the final Quality Review prior to filing.
- Responsible Quality member for oversight of all key Quality Systems associated with the development candidate including Complaints, Stability Reports (Expiry extensions), and Deviations etc.
EDUCATION AND EXPERIENCE
- Science degree preferably in life sciences and/or bio-engineering. PhD in these fields would be considered an advantage.
- Fifteen years of hands on CMC experience within a biotherapeutics development/ GMP operations facility, including 5 years plus in QA for Biologics. Periods spent in Quality at a Production Center would be considered advantageous.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
#LI-POSTCelgene 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.