Celgene Associate Director, Technical Services 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.

COMPETENCES

The Associate Director Technical Services oversees the full validation and maintenance activities for the Boudry OSD Manufacturing site. He/She is responsible to ensure the validated state of all processes, equipment and computerized systems for manufacturing and QC throughout the entire lifecycle.

In this role the person ensures at all time GxP compliance, EHS guideline adherence for his/her area of activities, whilst taking into consideration the company’s commitment to the Core Values and Behaviors.

This role is a strategic role and will be a key-player for the organization. This position interacts closely with the following departments: Bulk and Packaging Operations, Supply Management, QC and MS&T. In addition, the Assoc. Director Technical Services works in close collaboration and alignment with their peer based in Couvet ensuring aligned processes.

This position manages the teams dedicated to Validation Operations and the Maintenance & Metrology Department. The role reports into the site head and is part of the site Leadership Team.

SKILLS/KNOWLEDGE REQUIRED

  • MS in Pharmaceutical, Engineering or scientific related field, or equivalent relevant experience

  • 10+ years’ experience in the pharmaceutical industry

  • 6+ years of management experience in Validation Operations, experience in a maintenance required

  • Strong knowledge of regulatory requirements including FDA, Eudralex, PICS and GAMP

  • Demonstrated experience of regulatory health authorities audits; FDA, SwissMedic and others

  • Proven experience of new product introduction and technical transfer activities

  • Recognized for leading and motivating teams to accomplish sustained results,

  • Excellent team-building and communication skills

  • Proven leadership abilities to align, motivate, steer and empower team-members

  • Proven ability to work effectively within the department and cross-functional stakeholders

  • Strong analytics, solution oriented, and problem-solving skills

  • Drives the team to provide high standards deliverables and keep an eye for continuous improvement

  • Fluent in French and English

DUTIES AND RESPONSIBILITIES

Department management

  • Manage and develop the Validation and Maintenance & Metrology teams: performance management, capacity tools, and development and succession plans are in place

  • Define the strategy for the department: operating model, strategic activities and projects, in alignment with Celgene’s strategy and the supporting communication plan

  • Define, measure, monitor and the department’s key-indicators, ensure corrective actions are defined as required

  • Communicate pro-actively, consistently and collaboratively with the different stakeholders and partners

  • Propose, sponsor, and manage improvements and evolution projects

  • Foster communities of practices across Global Internal Manufacturing and with partnering departments as applicable

  • Participates to the investment strategy and budget definitions, responsible for the department’s budgets and long-range plans (OPEX and CAPEX)

  • Bring expertise and/or drive cross-functional / multi-site projects

  • Keep up to date with current industry best practices that may give an operational or strategic advantage to Celgene

Validation Operations

  • Oversees Validation master plan and ensure systems (facilities, utilities, equipment and local computer systems) and processes are qualified, validated and maintained throughout the lifecycle in compliance with procedures and latest regulatory requirements

  • Drive the validation execution related activities in a timely and qualitative manner as per business requirements.

  • Support product and technology transfer, including collaboration with MS&T and Drug Product Development with product & process development, scale-up and transfer, commercial control strategy, QbD and PAT

  • Ensure a risk-based approach is embedded; effort is commensurate to risk

  • Liaise with the Global Regulatory CMC team to ensure alignment and clarity between regulatory and commercial site documentation as required

  • Ensure that the activities requiring line-shutdowns are well communicated and agreed with the impacted departments and closed out in a timely and proper manner with minimum impact to commercial supply. Ensures all prerequisites are anticipated in collaboration with relevant departments.

  • Provide visibility of Validation activities and specifically when line-shutdowns to the stakeholders.

Maintenance & Metrology activities

  • Ensure Maintenance & Metrology related activities for all process equipment and utilities are maintained throughout their full lifecycle in compliance with procedures and regulatory requirements

  • Ensure that the Maintenance & Metrology related activities are delivered in a timely and qualitative manner as per business requirements

  • Oversee and communicate the yearly Maintenance shutdown organization and defines in collaboration with partners the ad hoc activities that will be executed during this period.

  • Ensure that the activities requiring planned line-shutdowns are well communicated and agreed with the impacted departments and closed out in a timely and proper manner with minimum impact to commercial supply. Ensures all prerequisites are anticipated in collaboration with relevant departments.

  • Ensure excellent service of maintenance activities is provided to the internal customers

Compliance

  • Responsible for the execution and tracking of all activities in compliance with GxP. This implies but is not limited to:

Accountable for the departments related topics during Health Authorities and Corporate audits/inspections

Process definition, SOP and WP management

Training Curriculum definition for the team as per business needs

Accountable for the team’s timeliness Training and of Quality System Records: such as: CAPAs, Deviations and Change Controls

  • Ensure internal procedures are aligned with corporate policies, regulatory requirements, international standards & best practices, including ASTM, ISO, CFR, EudraLex. ICH, WHO and PICs

  • Participate complex deviation investigations, change management, and critical quality complaint resolution activities

  • Work in collaboration with the other Manufacturing sites to ensure consistency of processes across the sites

EHS

Promote workplace operating compliance to EHS procedures and guidelines:

  • Line Managers shall provide a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.

  • Work closely with EHS to evaluate hazards and perform risk analysis, also for new product introductions

  • Ensure that staff is properly informed on hazards, and trained to act in consequence

  • Promote safe practices and behaviors, verify that EHS rules are implemented and respected

  • Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future

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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