What are the responsibilities and job description for the Tech Transfer Scientist (Cell Culture/ Upstream) - 100% REMOTE position at Rangam Consultants Inc.?
ob description
Must have experience with Cell culture tech transfer and development experience
Hands on experience with bioreactors (bench, pilot or production scale)
Summary of the group:
Members of the tech transfer function are responsible for transfer of upstream processes from process
development into clinical and commercial manufacturing. They work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to GMP manufacturing production.
Main Duties & Responsibilities:
Routinely transfer multiple projects as upstream tech transfer representative. This includes: Fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and management
Builds and maintains relationships with partner groups
Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
Effectively communicate and collaborate in a matrix team setting to implement technical solutions
Write technical reports and deliver presentations
Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities
Education & Experience Requirements:
A Bachelors or Masters degree in an engineering or scientific discipline. A focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
The candidate must have relevant industry related experience (BS 5-8, MS 2-5).
Required Skills:Cell culture tech transfer and/or development experience
Hands on experience with bioreactors (bench, pilot or production scale)
Fundamental understanding of upstream unit operations such as mixing, inoculum expansion, bioreactor, centrifugation, and filtration.
Knowledge of GMP manufacturing principles and documentation
Excellent written and verbal communication skills
Experience with data and statistical analysis
Desired Skills:
Experience with primary clarification via continuous centrifuge
Identify and solve complex manufacturing or bioprocess technical problems with limited data in a timely manner
Demonstrated ability to defend a technical position
Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
Fermentation or viral based production experience
Skilled in conducting process transfer/process development/technology development projects
Job Types: Full-time, Contract
Pay: $40.00 - $53.00 per hour
Benefits:
- Health insurance
- Life insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
- Bachelor's (Required)
Experience:
- upstream tech transfer: 5 years (Required)
- Cell culture: 5 years (Required)
- Bioreactor: 5 years (Required)
Work Location: Remote
Salary : $40 - $53