Senior Manufacturing Scientist (Drug Substance) (f/m/d) full time
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Hørsholm
For our site in Hørsholm we are seeking a motivated, open minded and experienced person as:
Senior Manufacturing Scientist (Drug Substance) (f/m/d) full time
Work within our Drug Substance manufacturing team to support the Tech transfer of production processes into our GMP facility. Drives facility fit and continuous improvement in manufacturing of Live Biotherapeutic Products (LBP) for our customers.
Your Profile:
Role and Responsibilities
Technology transfer
Implementing processes
Driving production activities
Commercial support
Are you interested to work for an innovative, dynamic, and future oriented start-up CDMO company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your cover letter and CV to Ms. Sandra Gamboni, Head of Human Resources; [email protected]
Kilde: Jobnet.dk
Senior Manufacturing Scientist (Drug Substance) (f/m/d) full time
Work within our Drug Substance manufacturing team to support the Tech transfer of production processes into our GMP facility. Drives facility fit and continuous improvement in manufacturing of Live Biotherapeutic Products (LBP) for our customers.
Your Profile:
- Min. a master’s or PhD degree in a relevant life science or engineering field (5-year education) or similar
- Min. 3 years’ experience with tech transfer or MSAT role in a manufacturing department within a life science or Biopharmaceutical sector.
- Demonstrated solid experience in fermentation technology and processes at production scale, preferably microbial processes.
- Knowledge of concentration and drying technologies in therapeutic applications.
- Knowledge of cleaning and/or process validation would be beneficial
- Proven track record of experience in working in a cGMP production environment
- Experienced in and comfortable with inspections and audits
- Excellent collaboration and communication skills, proactive, solution-oriented team-player
- Proven experience in working with Lean tools
Role and Responsibilities
Technology transfer
- Represents the Manufacturing team in Customer programs
- Partners with the Process Development department and represents manufacturing as the receiving unit for new manufacturing processes developed, ensuring facility and cGMP fit as process is being developed
- Ensures facility fit during the tech transfer from Process development to DS Manufacturing
- Manages planning and coordination of tech transfer activities in Manufacturing to meet the production plan
- Collaborates closely with the QA and QC Departments
Implementing processes
- Will function as the Process SME with Manufacturing
- Drives GMP readiness for new and existing manufacturing processes
Driving production activities
- Supports Manufacturing during the execution of DS processes, providing technical and scientific support throughout campaigns as required
- Coordinates major process investigations in response to major or critical deviations observed during manufacturing. Will consult and bring on board SMEs from other departments
- Supports in driving a culture of Operational Excellence, ensuring Bacthera delivers on KPIs associated with Right First Time and On Time Delivery
- Drives continuous improvement by coordinating lessons learnt after batches, sharing feedback and learnings with Development departments, and ensuring improvements are implemented
Commercial support
- Provides the input to Business Development and Project Management when scoping new customer projects within the area of production capabilities and performing ‘initial’ facility fit evaluation as part of customer prospect review
Are you interested to work for an innovative, dynamic, and future oriented start-up CDMO company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your cover letter and CV to Ms. Sandra Gamboni, Head of Human Resources; [email protected]
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 12.3.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Laborant
- Hørsholm
- Mandag den 12. april 2021
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Statistik over udbudte laboranter i Hørsholm over tid
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