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Scientist - Downstream Process Development
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Support, Engineering
Projektbeschreibung
Scientist - Downstream Process Development wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- Master degree or equivalent education in Biochemistry, Biochemical Engineering or a related discipline
- Practice with unit operations for the purification of biopharmaceuticals, such as chromatography, filtration and ultrafiltration in a development lab or manufacturing setting
- Know-how of evaluating technical integrity, quality standards and GMP compliance of manufacturing and regulatory documentation
- Skillset in presentation and scientific/technical writing as well as competency in management with respect to planning, tracking, priority setting for own activities and adherence to project timelines
- Languages: fluent English both written and spoken along with good German skills
YOUR TASKS:
- Supporting projects post IND/IMPD filing, providing process expert input and managing documentation related to GMP re-supply campaigns and regulatory filing updates
- Working on the development and scale-up of purification processes and related technologies for GMP manufacturing of protein pharmaceuticals
- Generating and reviewing process transfer documents as well as reviewing manufacturing master batch records, consolidated batch records and campaign experience reports
- Producing or updating source documentation to support regulatory filings worldwide and making sure that requirements of data integrity (ALCOA) are fulfilled
- Collaborating with CMC teams, under minimal guidance by senior project experts
START: ASAP
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13805
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- Master degree or equivalent education in Biochemistry, Biochemical Engineering or a related discipline
- Practice with unit operations for the purification of biopharmaceuticals, such as chromatography, filtration and ultrafiltration in a development lab or manufacturing setting
- Know-how of evaluating technical integrity, quality standards and GMP compliance of manufacturing and regulatory documentation
- Skillset in presentation and scientific/technical writing as well as competency in management with respect to planning, tracking, priority setting for own activities and adherence to project timelines
- Languages: fluent English both written and spoken along with good German skills
YOUR TASKS:
- Supporting projects post IND/IMPD filing, providing process expert input and managing documentation related to GMP re-supply campaigns and regulatory filing updates
- Working on the development and scale-up of purification processes and related technologies for GMP manufacturing of protein pharmaceuticals
- Generating and reviewing process transfer documents as well as reviewing manufacturing master batch records, consolidated batch records and campaign experience reports
- Producing or updating source documentation to support regulatory filings worldwide and making sure that requirements of data integrity (ALCOA) are fulfilled
- Collaborating with CMC teams, under minimal guidance by senior project experts
START: ASAP
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13805
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges