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Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If you’d like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
Requires a Bachelors of Science Degree with a Minimum of 8 Years Related Experience in GMP Environment.
Summary
Develops, implements, and maintains quality systems and activities to meet changing industry requirements and guidelines for a Pharmaceutical Development / Clinical Manufacturing Center. Champions improvement projects to promote operational and quality excellence. Strategic input into Complex Cell Based Development Projects .Coordinates interdepartmental activities for Quality Improvements, Change Management, Investigations Management Gap Analysis and Risk Analysis. Requires strong win/win negotiation skills / manage dept of two professionals.
Responsibilities are listed below to include ownership and responsibility for the site for all Compliance and Quality aspects.
1. Development Programs:
• Good working knowledge of Pharmaceutical CMC Development Process to give Quality
Dept input into Development changes in Cell Culture Manufacturing and QC testing.
• Participate in new product development and IND submission preparation to ensure
compliance requirements are met. This includes raw material qualification, product.
release specifications, QC test / retention sample requirements and validation review and
approval.
2. Sterile Clinical Manufacturing:
• Quality oversight of aseptic manufacturing areas that handle production of Master Cell /
Working Cell Banks, together with development and clinical dose lot production.
• Review and approve changes to the sterile Core manufacturing facility, including the Cryo
Bank storage systems and clinical trial cryo shipment supply chain.
3. Quality Management:
• Perform Gap Analysis and or Risk Analysis of all quality focused systems to identify and
remediate quality issues.
• Review and collate quality information for inclusion into the Annual Product Review and
IND updates.
• Identify quality initiatives and provide strategic and tactical planning to support
implementation and monitoring activities.
• Monitors compliance posture by tracking and trending quality issues within site and adds
an overall industry perspective. Keeps Functional Area Management informed of quality
system trending.
4. Product Release:
• Review of batch records to insure product meets release criteria, raw material
specifications etc have been met ,aseptic techniques are followed, labeling meets
specifications and all non-conformances are closed prior to release.
• Lead investigations, risk analyses and resolve issues related to product quality.
5. Quality Systems:
• Design /Implement and maintain oversight of CCT Quality Systems across Departments
and functional areas. This includes:
? Non-conformance
? Complaint
? Document and Change Control
? Record Keeping – primary and secondary batch records
? Training
? Supervise CCT day to day QA staff activities associated with site Quality Systems.
• Perform surveillance on industry standards and regulatory requirements in order to
recommend improvements to the Quality Systems and procedures and processes within
CCT.
• Interface directly with other department directors/managers for problem solving and
improvement projects.
6. Audit:
Regulatory and Certifying Agency and Corporate QA Audits:
• Represent the CCT Quality System to auditors from federal and state agencies and
certifying bodies. Record and distribute a transcript of all audit activity, conversation, and
observations/recommendations. Summarize observations and initiate non-
conformances. Oversee the initiation, preparation and closure of resultant CAPA.
• In conjunction with QA Management and Functional Area Management, prepare
response to audit findings.
Internal Audits – CCT QA
• Design and oversee the audit of CCT departments on a regular and timely basis.
• Oversee preparation of the report of any findings. Provide effectiveness monitoring as
needed.
• Provide oversight for implementation of any corrective/preventive actions that result.
External Audits – CCT materials manufacturers and suppliers
• Coordinate audits of materials and services suppliers with Corporate QA/Compliance.
• Review audit reports with relevant CCT managers.
• Resolve supplier quality issues.
7. Material Qualification:
• Review and approve Raw Material Monographs to insure materials meet requirements for
product quality and compliance.
• Provide supplier assessments in cooperation with Development, Manufacturing,
Purchasing, and Corporate Quality/Compliance.
• Review and approve labeling for in process and final product identification according to
applicable regulatory requirements and local SOPs.
• Coordinate and schedule supplier audits through Corporate QA/Compliance; approve
vendor/supplier assessments. Monitor vendors / suppliers for compliance / quality issues.
8. Training:
• Develop, prepare and present training for CCT staff in GMP/GTP and other topics as
needed. Assist other CCT managers with training presentations related to CCT
procedures.
Compliance Systems: Implements and maintains the policies and procedures of the divisional Quality Systems.
Communications: Communicate, work with and provide timely service to staff and internal colleagues in Manufacturing, Quality Control, Development, Corporate QA/Compliance, and Corporate Training.
Skills/Knowledge Required:
• Bachelors Degree in a scientific discipline with at least 8 years previous experience in GMP manufacturing.
• High degree of organizational skills with strict attention to detail.
• Ability to communicate effectively and function cooperatively with other staff, management and auditors. Ability to supervise and schedule staff.
• Ability to recognize the need for and effect improvements.
• Knowledge of MS Word, MS Excel, and the ability to learn new computer skills as needed.
• Good understanding of and ability to interpret cGMP, licensing and certification requirements. Knowledge of current regulations governing Development of Biologics and Pharmaceutical GMPS and the ability to apply to the relevant CCT areas.
Equal Employment Opportunity
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
19245197
Posted / Updated:
5/5/2010 3:38:48 PM
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