For our Client, a leading Biotech Company located at Düsseldorf, we are currently looking for this permanent position
Senior Scientist (m/w/d) Manufacturing Science & Technology
- Support to manage the site’s Manufacturing Science and Technology (MST) organization. MST services include optimization of upstream and downstream manufacturing operations, scale up, and technology transfer of manufacturing processes.
- Could act as MST head deputy
- To lead experimental work in laboratory using and establishing scale-down models of manufacturing processes and act as lab manager
- To support that sufficient staff and resources are available to provide MST services in a timely manner to meet site and business goals.
- To ensure that MST services are compliant with the site’s quality standards, practices, procedures and documentation requirements, and with site, local, and federal safety requirements.
- Support to manage MST projects and staff to ensure that timelines, quality, safety, and cost objectives are met.
- To apply appropriate technical standards for processing, packaging and materials, where applicable, employing the concepts of Quality by Design (QbD), Design of Experiments (DOE), and Process Analytical Technologies (PAT).
- To manage and participate in the execution of process improvements, scale-ups, and justification / verification projects. Ensures that the process justification /verification batches generate sufficient process knowledge by thoroughly testing critical variables.
- To collect and report KPIs to enable meaningful CPP / CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
- In collaboration with other Dynavax functions, ensures that both transfer and new product launches will be executed right first time in terms of correct technology match (equipment, materials) and effective handover to the manufacturing operations.
- To contribute to the continuous improvement of manufacturing processes and procedures with regard to yield, throughput, quality, and safety by GMP compliant means, such as change control
- To develop staff to ensure that services are executed according to approved procedures.
- To coordinate and collaborate with manufacturing and quality departments to ensure appropriate coordination and oversight of MST activities.
- To identify, investigate, and participate in the resolution of compliance issues and deviations and to support the identification and implementation of corrective and preventive actions (CAPAs)
- To conduct self-inspections to ensure regulatory inspection readiness
- To perform, supervise, or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of overview reports, and reporting of relevant metrics.
- To represent MST and to provide MST-related expertise in various internal and external meetings.
- To lead or participate in meetings to direct others, or to report on, contribute to, and / or resolve job-related matters.
- To complete assigned trainings in a timely fashion to ensure that both personal and department training status meets Department and site expectations.
- To collaborate with (site) management to identify training opportunities for self and team development.
- To ensure that MST team is trained and current on applicable global directives, site procedures, and meet minimal job description requirements.
- Bachelor’s degree or higher in Biotechnological, Chemical, Engineering, or related scientific or technical discipline from an accredited technical university.
- 6 + years of relevant work experience managing scientific based services in a vaccine, biologicals, or parenteral pharmaceutical manufacturing environment.
- Fluency in English and German both written and spoken
- Working knowledge of current federal, local, and international regulations regarding the production of drug substances and drug products.
- Good understanding of cGMP’s, industry and regulatory standards and guidelines.
- Good understanding of federal and local regulations regarding occupational safety and health within a manufacturing environment.
- Excellent interpersonal skills and leadership potential.
- Experience working with cross-functional teams.
- Strong ethical foundation and a sound compliance understanding.
Bei Fragen steht Ihnen Steffen Rademacher unter der Telefonnummer +49 211 92 410 190 gerne zur Verfügung.