Upstream&Downstream Process Manager (Ds Manager) İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
What we are looking for:
- Bachelor's or master's degree from biology, bioengineering, molecular biology or chemical engineering departments of universities,
- Having 10 years or more experience in the biopharmaceutical industry related to the development and production of monoclonal antibodies and protein processes,
- At least 5 years of experience in managerial positions,
- Laboratory and industrial scale upstream and downstream process experience,
- Experienced in monoclonal antibody and protein production and purification in mammalian cells,
- Experience in viral studies in mammalian cells and purification studies,
- Experience in Quality by Design and Design of Experiment,
- GMP experience
- Upstream and downstream process experience in GMP conditions,
- Experience in technology transfer (to the facility and from the facility),
- Experience in upstream/downstream management,
- Open to the changes in the work environment,
- Able to keep up with the intense working,
- Having good report writing skills
- Having ERP and quality assurance system knowledge,
- Familiar to occupational safety rules,
- Result oriented, researcher, having advanced problem solving skills,
- Analytical thinking and strong communication skills,
- Fluent in English,
- Good knowledge of MS Office programs.
- Preferably residing in Anatolian site of İstanbul or Gebze
Major Tasks and Responsibilities
- Provides technical leadership and expertise for investigation and resolution of upstream and downstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation, and preparation of regulatory filings.
- Responsible for taking a leadership role in the day-to-day operations of the upstream and downstream manufacturing, conducting and evaluating training for new or current team members and delegating tasks appropriately. To coordinate and manage all operations of the staff working in the upstream and downstream process department.
- Ensures and approves the preparation of standard operational procedures (SOP), batch records, working instructions and forms associated with upstream and downstream processes
- Prepares / approves process validation protocols, process validation plans, protocol implementations and summary reports for upstream and downstream processes to support the process validation studies required for GMP production
- Establishes/Develops an upstream cell culture process that is suitable for GMP manufacturing and ensure that upstream processes perfomed compliance with GMP.
- Ensures that research cell banks (RCB), research-working cell banks (RWCB), post-production cell banks (ExCB), master cell bank (MCB) and working cell bank (WCB) are established in compliance with GMP.
- Responsible for signing the order and delivery forms, equipment service reports and out of specification, out of trend and deviation forms required for upstream processing. Authorized to change process parameters and set points of the upstream processing steps within the change management procedure.
- Defines and sets up process monitoring systems, analyze process trends and monitor process performances to maintain robust manufacturing process (quality, capacity)
- Supports the preparation of process evaluation reports, process transfer documentation, and process characterization presentations
- Providing of planning and implementation of laboratory-scale purification studies for improving the efficiency and product quality of existing manufacturing processes
- Designing and performing filterability studies for selection of filter type and surface area required for filtration processes
- Designing and performing screening and optimization studies for biopharmaceuticals
- Designing and performing scale-up studies of upstream and downstream process steps and applying technology transfer to manufacturing site
- Performing and controlling of GMP manufacturing upstream and downstream processes and filling related documents
- Performing upstream and downstream process validation studies
- Planning and implementation of transfer studies of upstream and downstream manufacturing processes developed by international expert organizations
- Supporting for planning and establishment of cell culture, process development, protein purification laboratories and GMP biopharmaceutical manufacturing areas in order to established for the development and manufacturing of target proteins in TURGUT.
