Other Locations:Switzerland- Boudry
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.
Celgene International Lab Ops is committed to provide QC support to the Celgene International manufacturing site, key contract manufacturing organizations and other Celgene departments. The Lab Ops function ensures either on Celgene manufacturing sites or at contract manufacturing organizations the cGMP compliant execution of the analytical processes and ensures Celgene products are available for the markets and to the patients as required.
The position holder is considered an analytical expert for Biological drug substance and Biologic Drug product analytical test methods, test method validation and test method transfers both internally and also externally.
This position is responsible for quality control (QC) tasks such as Drug Product quality complaints handling from a QC perspective and QC management of assigned critical vendors for aseptically manufactured Celgene product. The Associate Director, Laboratory Operations Biologics, furthermore executes QC functions such as performing deviation, investigation, CAPA, method transfer, and change control tasks as needed.
As a key member of the Celgene Global Laboratory Operations team, this position will be working with the other partners of the Global Laboratory Operations team and the Corporate Quality organization to collaborate on the different Quality Topics and projects assigned.
Duties and Responsibilities
The position holder is responsible for the tasks below. The list of tasks is non-exhaustive, according to business needs other tasks might be assigned to the position holder.
- The job holder is an expert in Biological testing and also testing strategy, this would include the full analytical life cycle form development phase III through transfer and then control.
- Reviews and updates procedures for the Quality Management System of Celgene International as per process ownerships and business needs.
- Provides QC support, advice and information to the various user departments within the organisation for the above listed quality topics
- Supports the QC function by addressing deviations, investigations and CAPAs pertaining to assigned quality topics – Supports, coordinates and/or documents investigations related to the Recall/Mock recall process as per business needs.
- As QC Laboratory representative coordinates and supports the VQA with approving actively assigned vendors in the completeness of the following tasks involved (non exhaustive list):, vendor qualification, Stability program management including protocol and reports, provide support and guidance to the VQA in handling of vendor deviations (Both OOS and OOT) and change control, coordination of manufacturing investigations (e.g. complaints investigation), communication of changes in specifications to contractors and suppliers, communication with CQM for vendor status, identification of potential gaps, QC tasks triggered by regulatory submissions, etc. – Provides Senior Management with appropriate vendor related KPIs as required, communicates relevant vendor related QC information within Celgene as appropriate.
- As QC Lead for new projects or new products to be implemented at assigned vendors sites:
- Participates to project meetings as appropriate,
- Defines the necessary action plan for QC aspects,
- Coordinates the implementation of resulting actions with the vendor and within Celgene,
- Reviews (or coordinates the review) and approves associated vendor QC documentation as required,
- Communicates relevant vendor related QC information within Celgene as appropriate including liaison with project Technical Lead.
- Acts as QC representative (SME) during authority’s inspections and contributes in various roles to the successful execution of authorities audits (backup host, note taker, back office, runner, etc).
- Contributes as lead auditor or audit team member to internal audits, external audits and vendor qualifications (manufacturers and laboratories) managed by QA Compliance function.
- Provides instructions for the constant development of the Celgene International Quality Operations KPI’s.
- Represents Celgene International Quality Operations as part of project teams formed for the implementation of new Global Quality Management electronic tools and software; is responsible for the implementation on the Celgene International manufacturing site of the appropriate module(s) pertaining to assigned quality topics.
- Contributes as lead auditor or audit team member to internal audits, external audits and vendor qualifications (manufacturers and laboratories) managed by the Corporate CQM (Compliance & Quality Management) group
- Provides support to Celgene Corporation and Celgene Europe concerning requests for investigation or information pertaining to assigned quality topics
- Leads or participates to international working groups pertaining to assigned quality topics
- At least 10 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company.
- Minimum (BSc) in Biology, Chemistry or Pharmacy, science or related field; MSc, PhD/Pharm D an asset.
- Thorough understanding of cGMPs and FDA regulatory requirements.
- Solid understanding of Biological dosage form manufacturing processes and QC testing methods including Microbiologic and Sterility testing.
- Experience with external third party liaison especially with contract laboratories.
- Solid understanding of the aseptic manufacturing processes and QC testing involved in the pharmaceutical industry
- Good understanding of QP concept and associated duties including liaison with Health Authorities.
- Works independently, yet effectively in a team environment.
- Ability to focus and attention to details.
- Excellent communication skills in English.
- Excellent investigational and problem-solving skills.
- Analytical mind, ability to assess new products or new projects to define and implement the appropriate action plan for integration into the Celgene International Quality System
- Knowledge of most common office software (Microsoft Office).