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发帖数: 48 | 1 A Fortune 500 Healthcare company in New Jersey is hiring Scientist/Senior
Scientist for Biology Process Development
Job Description:
- Develop T-cell proliferation process (USP and DSP) and transfer for
current and future AT (Advanced Therapy = Cell & Gene Therapy)projects.
- Contribute to build development facilities and resources for T-cell
proliferation process development for current and future Advanced Therapy
projects.
- Contribute to interdisciplinary technical development work.
- Participate process development activities
- Fulfill all related tasks and responsibilities related to own discipline.
- Proactively communicate key issues and any other critical topics in a
timely manner to the appropriate management level and/or to any other
relevant project team member(s).
- Design, plan, perform and monitor all assigned activities.
- Ensure quality, quantity and timelines in all assigned projects.
- Interpret and communicate results, evaluate data, draw relevant
conclusions and write reports. Contribute to optimization of scientific/
technical activities.
- Contribute to optimization of processes within own area of
responsibilities.
- Contribute to risk analyses and/or peer review and process challenge
meetings.
Desired Skills and Experience
- Minimum requirements BS or MS or equivalent in Cell Biology / Immunology /
Bioprocessing or related sciences.
- At least 1 years of relevant experience in process and medium development
for processing (isolation, selection, activation, proliferation in
suspension culture, process automation, separation and cryopreservation) for
primary cells (T-cells, steam cells) for autologous and allogeneic cell
production is preferred
- Strong fundamental knowledge of cell biology, immunology and cell culture
process technology is required.
- Proven track record in utilization of special tools/equipment, lab
automation tools and specialized facilities e.g., containment/sterile labs.
- Hands-on interest and experience with adherent and suspended primary cell
cultivation, primary cell separation equipment and respective analytical
methods is a must.
- A sound knowledge and practical experience in statistics (incl. DoE) is
expected.
- GMP experience and a strong knowledge of relevant regulatory guidelines (
FDA, EMEA, ICH) is preferred.
- Plant design experience for patient specific cell proliferation and
processing equipment and cabinets is preferred.
- Further requirements include team player with strong communication,
established presentation and scientific/technical writing skills, good
management skills with respect to planning, tracking, priority setting and
adherence to project timelines
- May require up to 25% travel.
If interest, send cover letter and resume to: [email protected]
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