Celgene Associate Director, CAR-T Operations & Logistics in Boudry, Switzerland

Description

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.

Associate Director, CAR T Quality Supply Chain & Logistics

Location:

Boudry, Neuchatel CH

Job Category:

Quality Assurance

Work Location:

Route de Perreux 1 BOUDRY 2017

Organization:

Global Pharmaceutical Development & Operations (GPDO), Celgene Corp.

Schedule:

40 hr/wk

Shift:

n/a

Employee Status:

Full time

Job Type:

Regular

Job Level:


Travel:

Regional travel up to 45% within Europe

Other Locations:

Germany

DESCRIPTION

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.

POSITION

Associate Director, CAR T Quality Supply Chain & Logistics

SUPERVISOR

Director, CAR T Quality

DEPARTMENT

Global Pharmaceutical Development & Operations (GPDO)

PREREQUISITES

10 plus years’ experience in the pharmaceutical industry in Biotech or Cell & Gene Therapy

SCOPE

The Associate Director of EU Quality CAR T Apheresis Operations is responsible for providing Quality oversight of regional contract service providers and service providers within the CAR T network, including Apheresis Centers used for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies and couriers/transport providers.

This role is accountable for the quality oversight of operations starting from patient apheresis collection, packaging, and transport to Celgene manufacturing facility for drug product development and the delivery of drug product back to the treatment center for patient infusion.

Scope of for this role includes quality oversight of Apheresis Center blood donor collection centers including site assessment, screening due diligence, business onboarding, site contracting, CAR T process training, center qualification, ongoing center compliance, patient scheduling, shipping and logistics for T-Cells, risk management, service/quality agreements for external services, and ongoing performance management of the regional network of Apheresis Centers.

This position will be at Celgene International Headquarters located in Boudry Switzerland, and will serve as the Quality oversight of CAR T Aphereisis Operations and logistics within Germany.

Responsibilities may include, but are not limited to, the following

  • Support the starting material (apheresis centers, blood banks) approval processes, providing guidance related to the GMP approval process and requirements in compliance with CAR T and Celgene Standards.

  • Support auditor in audits of Celgene starting material and service providers as subject matter expert for CAR T. Support Quality Due Diligence assessments as needed.

  • Quality lead to ensure the monitoring and completion of audit CAPA plans/quality improvement efforts, including authority to assess documentation for adequacy to close Celgene audit findings.

  • Responsible for initiating Quality Agreements with assigned collection centers and service providers. Establishment/maintenance (periodic review/update) of any required Quality Agreements with assigned global material supplies and service providers.

  • Act as Single Point of Contact to ensure all quality-related activities are completed according to CAR T and Celgene requirements.

  • Responsible for driving/initiating risk assessments for assigned projects, related to initial approval and routine monitoring requirements as defined in CAR T procedures and Celgene Standards.

  • Act as Single Point of Contact for all quality-related activities of assigned EU starting material suppliers and service providers, supporting approval and establishment.

  • Responsible for routine monitoring and oversight of assigned EU starting material suppliers and service providers (including on-sight oversight as needed, assessment of supplier initiated changes, management of global change control, assessment of deviations, investigations, and CAPA).

  • Support approval and establishment of human cells and tissue (HCT) starting material suppliers (e.g. apheresis blood donor collection centers, blood banks), including potential site assessments, site/collection center training, and coordination with internal Celgene groups (e.g. clinical operations) where applicable.

  • Manage the routine monitoring and oversight of HCT starting material suppliers (including on-sight oversight as needed, assessment of supplier initiated changes, management of global change control, and assessment of deviations, investigations, and CAPA).

  • Responsible for providing support for shipper qualification and shipping deviations, CAPAs. Working closely with a cross functional team to confirm a robust Chain of Identity process is in place.

  • Provide additional cross-functional support for other groups within CAR T QA as directed by management. Within the organization:

  • Support the implementation and maintenance of a local Quality System and Standard Operating Procedures for CAR T QA and the functions of the Supplier Approval group.

  • Ensure the QA management is kept informed of all critical and major issues which may have an adverse effect on the quality of the CART products or effect program timelines.

  • Monitor Key Performance Indicators and ensure that all parts of the Supplier Approval QA organization are working in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures.

  • Ensure that coordinated contact is maintained with other functions within Celgene including Quality, Compliance & Auditing, Commercial BD, Clinical operations QA, Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Global Quality Operations (GQO), etc.

  • Provide accurate and compliant guidance that is flexible and appropriate for the product/project phase; based on and compliant with policies/standards/SOPs established at Celgene.

Personal development & people development

  • Maintain current knowledge of local and international regulatory and legislative requirements and trends.

  • Support development of QA associates with respect to product and process knowledge.

  • Provide mentoring of junior QA associates

KEY PERFORMANCE INDICATORS

  • Training plans in place with training conducted, assessed and documented

  • Execution of assigned responsibilities in a timely and efficient manner

  • Robustness of risk mitigation (CAPA closure effectiveness, supplier management)

  • For assigned projects, performance against established KQIs, including timeliness of CSP approval, number of overdue deviations/investigations, etc.

SKILLS/KNOWLEDGE REQUIRED

  • Experience in QA Operations, production, QC and/or other relevant operational areas, but must include some QA experience

  • Thorough knowledge of cGMP requirements and ICH guidelines

  • Strong understanding of regulatory requirements for commercial products

  • Interaction with health authorities (e.g. FDA, EMEA)

  • Participation in GMP or GCP audits as a support or lead auditor

  • Strong understanding of risk assessment and risk management fundamentals/tools

  • Technical understanding of pharmaceutical processes

  • Team and consensus builder, with definitive and authoritative decision-making ability

EDUCATION & EXPERIENCE

  • Bachelor or higher in Biology, Biochemistry, Virology, Microbiology or another related science

  • Ten or more years’ experience in the pharmaceutical industry in biotech or cell and gene therapy

  • Five plus years in pharmaceutical QA

  • Direct experience with blood products, or blood banking, or HCT (e.g. blood collection; apheresis), or HCT eligibility assessments is preferred

  • Experience working with CSP manufacturing or supply relationships

LANGUAGE

Written and verbal fluency in several languages (English, German, French)

FOR FURTHER INFORMATION, PLEASE CONTACT HUMAN RESOURCES

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.

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