Informationen zur Anzeige:
Junior Scientist (m/w/d)
siecon personalmanagement GmbH
Biberach an der Riß (DE)
Aktualität: 04.09.2024
Anzeigeninhalt:
04.09.2024, siecon personalmanagement GmbH
Biberach an der Riß (DE)
Junior Scientist (m/w/d)
Aufgaben:
- Responsible for projects of the team in process Microbiology (e.g. compliance topics, paperless processes) and professional/scientific support of internal and external partners.
- This includes the improvement of current processes, development of new strategies (e.g. globally aligned contamination control strategy, foster digitalization), and support of new rapid microbiological analysis (e.g. Growth direct system).
- Responsible for the implementation of new coordination methods resulting in improved cooperation management among the costumers units (e.g. qualification work).
- Independent representation of the IPC Microbiology within cross-functional teams (e.g. BGS, Bioburden Remediation Program, GlobalEM, Endotoxins).
- Responsible for an appropriate, timely, and competitive accomplishment of complex cross-functional working packages by following all relevant pharmaceutical rules and regulations like ICH, AMG, AMWHV, GMP, compendial demands as well as BI internal relations and SOPs.
- Responsible for a timely closure of compliance gaps resulting from CAPAs, CCs, audit/inspections, etc.
- Responsible for the inspection and audit readiness of the team IPC Microbiology. Representative of the Laboratory Head of IPC Microbiology within audits and inspections including the autonomous preparation and presentation of topics.
- Responsible for continuous tracking and implementation of relevant regulations in the US, EU etc. regarding microbiological topics (Bioburden/ Contamination control, EM and Endotoxins) and GMP.
- Responsible for filings or SMF/DMF regarding microbiological monitoring program/results for drug substance and drug product manufacturing.
- Living the costumers safety culture (global EHS standards) and support an open, creative, innovative, trust worth, continous learning, proactive culture focused on business goals.
Qualifikationen:
- Diploma/Master's degree (e.g. MBA, MSc), preferably with Ph.D., in Biology, Biotechnology, Pharmaceuticals or in a related scientific discipline or comparable qualification with longtime experience
- More than 5 years experience in quality control and/or manufacturing of biopharmaceuticals of the (bio-)pharmaceutical industry, preferably for analytical IPC methods
- Excellent knowledge and experience in microbiology, related national and international regulations and GMP aspects, e.g. EMEA, FDA, EP, USP, JP
- Solid project management and negotiation skills, preferably 3 year experience in leading matrix teams
- Strong problem solving and risk assessment skills
- Excellence in driving results in a changing environment
- Excellent customer and business goals orientation
- Strong communication and presentation skills in German and English.
Standorte