Celgene Specialist, External QA, CAR T in Summit, New Jersey
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.
- PURPOSE AND SCOPE OF POSITION:
The Specialist, External QA, CAR-T is responsible for supporting the Batch Record Review from a Subject Matter Expert (SME) standpoint and the batch review process by ensuring accurate and timely maintenance and review of manufacturing batch record/testing documentation; performing final review and contract manufacturer’s batch record and summary of testing documentation.
The Specialist, External QA, CAR-T is required to act as SMEs for their individual areas of expertise in the batch review process and engage in monitoring the documentation process from manufacturing through release of the product to market and understanding of fundamental scientific or manufacturing related problems.
The Specialist, External QA, CAR-T is required to have technical review experience in the SME designated function and be able to documents technical and scientific issues with expertise and clarity. Data/Investigation reports generated should be concise and precise, for the intent of getting the issues reported and investigated thoroughly. All written and oral communication should be provided with clarity and accuracy for escalation and reporting of issues internally and externally with CSP.
- REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Must have expert GMP, Quality, and in-depth risk management knowledge;
· Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy;
Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function;
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams;
Must develop employees and coach them to bridge knowledge gap;
Most have strong authorship and beable to critically review reports while effectively inputting and expressing Quality risk management principles;
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking;
Must possess an independent mindset and tenacity;
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision;
Consults management for advice on complex issues;
Work is self-directed;
Confident in making decisions for minor issues
Routinely recognizes Quality issues and solves problems; escalates quality issues when appropriate;
Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned;
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution;
Recognizes risk and develops contingency plans. Understands the basics of continuous improvement and improves efficiency and productivity within the group or project;
Is recognized Subject Matter Expert within the group;
Provides guidance to other employees in interpretation of complex data;
Capable of providing input within the department and cross functional teams;
Builds relationships internally within and with cross functional teams;
Contributes to goals within the work group;
Able to recognize conflict and notify management with proposed recommendations for resolution;
Shows basic negotiation skills within work group and team;
Broadening GMP and Quality Knowledge;
Able to prepare written communications and communicate problems to management with clarity and accuracy;
Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge;
Understands fundamental scientific problems;
Able to write and review reports with clarity and brevity;
Able to produce data reports with precision.
- DUTIES AND RESPONSIBILITIES:
Assists with the maintenance of testing procedures required for the review process for proper versioning for Celgene products/test methods/specification as required;
Significantly contributes to timely review of contract manufacturer’s batch and summary of testing documentation and reported issues and exude confidence in making routine decisions related to their SME area on addressing and management of path forward with minimal oversight;
Capable of providing input with department and cross functional teams, including CSPs, for administration, receipt, review of CSP documentation corrections
Participates in routine meetings internally and with CSPs in order to follow-up that requirements are being met;
Reports into QO Batch Review Group meetings as required to update on the status of documentation review and pending items holding release, including any global issues;
Performs training of Vendor Quality Manager (VQM) review/disposition requirements, for both internal and external personnel as needed;
Generates review documentation and prepares batch disposition documentation;
Responsible for the pre-disposition review for batch review;
Generates CofAs and CofCs for batches as required;
Required to perform tracking and trending of the batch review process, CSP batch review data as well as Incoming Quality Control data;
Supports Qualification Process for designated CSPs. Works with CSPs to try and assimilate what will be required going forward to work towards this process, if not already qualified;
Act as backup for final batch disposition as required;
Provides support to VQMs and Quality Compliance Managers as required;
Supports site Management Review and MQR/PQR process for site;
Supports systems to facilitate timely finished product batch review. Performs investigations as required. Follows up to ensure corrective actions are implemented. Initiates/supports Management meetings/projects to facilitate timely product batch review
Maintains knowledge of current GMPs and regulatory guidelines;
Performs supplemental investigations/projects as required by Management.
- EDUCATION AND EXPERIENCE (As Applicable):
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
- 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.
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.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.