Lab Engineer

GeelIPharmaceutical Sector

Job description Select Projects is looking for a pharmaceutical company for Lab Engineer. The role can be done remotely after a training period.

Your tasks will consist of
  • Responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
  • Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
  • Coordinate and manage qualified materials program. Coordinate/Lead multiple site/global projects and represent QC across organizations.
  • Contribute to the operation of Stability and Quality release testing programs across a multi[1]product portfolio, managing timelines to meet corporate goals.
  • Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
  • Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
  • Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
  • Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA; Contribute to stability and quality sections of Annual Product Review
  • Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
  • Complete sample submission forms; Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews
  • Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
  • Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
  • Contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site
  • Maintain department and project metrics, as appropriate.
  • Support the company oversight of procedure and document changes at CLOs.
  • Participate in routine internal and external Operations Meetings
  • Frequent inter-departmental, inter-organizational and external interactions
  • Reviews and compiles data for CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed
  • Support the development and management of quality agreements between Sanofi and internal/external parties
  • Financial management and planning of analytical purchase orders for CLO testing activities and reagents, as well as any other planned analytical activities under responsibility
Profile
  • Bachelor of master in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry
  • Knowledge of Dutch and English (written and spoken)
  • In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment
  • Analytical and quality mind-set, organized, communicative, flexible, eager to learn and enthusiastic
  • Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers).
  • Experience in
    • GMP
    • Analytical GMP methods of biologics/antibodies (release and stability of drug substance, drug products and diluent testing), both compendial and non-compendial methods.
    • Investigations, Deviations, change controls, CAPAs, method improvements and gap assessments.
    • Familiar with regulations (EMA/FDA/…)
Organisation and department description At Select Projects, the client's experience with our staff is our main focus. It is our consultants who ensure an optimal experience by delivering the highest quality. Your expertise is central to this and you can continue to grow at Select Projects, so that you become and give the best version of yourself. As a consultant, you bring knowledge and skills and you have the will to succeed. What is in return?

Select Projects offers interesting projects, growth opportunities, autonomy, trust, training and professional colleagues you can learn from. This allows you to work on your professional growth and personal development. At Select Projects, you are not only part of the team at the client. You also form a team with your fellow consultants in the field. We have family values where we help each other and pay attention to each other. This allows you to become and give the best version of yourself. Working at Select Projects means that you are working on your craftsmanship and are therefore the specialist in your field.Offer You will receive an attractive salary package with interesting additional benefits. A company car, meal vouchers, group insurance and eco vouchers are among the possibilities.

We ensure that you end up in a pleasant work environment with nice colleagues and opportunities to develop yourself and further. Together with you, we will map out a training route according to your future plans and current needs.
Any questions?
Sakina El Kasmioui Talent Acquisition Specialist +323 600 08 65
Lab Engineer Vacancy information
97035
Life Science
Project Sourcing
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