Fast Trak Scientist

Role Summary/Purpose
We are looking for a Downstream Scientist for Fast Trak, a global group that oversees the global biopharma industry and provides application support in the form of process development, consulting and/or training to the industry and academia. The position is in a highly dynamic group and provides many opportunities for individual career development.

Essential Responsibilities

Duties include (but are not limited to):

Working directly with customers in a strong collaboration environment
Assisting with Fast Trak Process development Projects, autonomous execution and planning of experiments in the lab as part of the projects, participation in scientific discussions.
Assisting independent scientific application work on key projects (Monoclonal Antibodies, vaccines, recombinant proteins, plasma fractionation)
To host/train Customers (internal/external): delivering lectures and/or participating in the coordination of the experimental part of the course
To maintain accurate and complete records of all work, and report to customer and management in oral and written manner
Occasional global travelling up to 25%
Assisting in activities for adding value to GE?s customers by identifying continuous improvement opportunities in their bio-manufacturing processes and designing and implementing innovative process enhancement
Assisting with Fast Trak Process development Projects in the lab and in report writing.
Helping with Lab maintenance.
Supporting, teaching laboratory exercises
Assisting independent scientific application work on key projects (Monoclonal Antibodies (MAb's), vaccines, recombinant proteins, plasma fractionation)

Quality Specific Goals:

Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives

Qualifications/Requirements

Masters degree in Chemistry, Physics, Biomedical Engineering, Chemical engineering or related Life Sciences field
Some years industrial experience in bioprocess development, scale-up, tech transfer or manufacturing, GMP regulation, R&D and/or process development experience
Able to operate in a high pace environment with frequent changes
Demonstrated good presentation skills
Demonstrated advanced English skills both written and spoken

For more information regarding the position please contact hiring manager +46 186120291

Desired Characteristics

Strong industrial experience in Downstream processing of biomolecules (filtration, downstream, technology transfer, validation, process development, biomanufacturing)
Understanding of principles and theory behind unit operations for processing biologicals with knowledge in principles of scale up, validation, disposable, hybrid and traditional set ups and GMP manufacturing
Working knowledge of FDA/EMEA regulations for biologics (Phase I-III and manufacturing)
Column Packing Experience
HTPD experience
Experience with Unicorn? and Assist softwares