| Job Description | Job Description:
Qualification and Experience:
BS/MS in Life Science, Engineering or equivalent. 0-4 years of experience; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement.
Job Responsibilities:
This position will initially report to the Head of Upstream Development with responsibilities including but not limited to:
Process Development(40%)
Plan and execute experiments performed to evaluate cell lines/strains, culture media, feeding strategies and process conditions.
Work in collaboration with Operations group to execute protocols, experimental plans, and critical production batches.
Represent functional area in team meetings as required.
Author experimental plans, reports, and operating procedures.
Maintain a current laboratory notebook with scientific rigor to meet project needs for process development.
Implement state of the art science and technology with respect to media development, cell line development, primary recovery, and bioreactor systems while exploiting miniaturization to the extent possible.
Collaborate with other function to deliver an efficient low cost solution to customers.
Develop effective mammalian/fermentation scale-down capabilities and implement effective and scalable process control strategies.
Media design and optimization for mammalian cell culture and microbial fermentation process development at various scales.
Equipment and Facilities (30%)
Participate in design and start-up of facility and process equipment. Partner with vendors to deliver state of the art technologies.
Innovate technologies that enable the miniaturization of development systems and increase the efficiency of process development
Develop efficient and innovative solutions to enable multi-host development and cGMP facility design and operation.
Follow full GMP guidance and fulfill all Quality Assurance requirements where required.
Operate safely and according to company environmental requirements.
Culture (20%)
Evaluate technologies and propose ideas for innovation.
Support business development activities as required.
Present data or ideas in team meetings.
Follow all company best practices to minimize cost and meet budgetary requirements.
Head of Process Development & Manufacturing may assign other responsibilities as required. |
| | Company | | Oncobiologics, Inc. | Job Code | | State or Province | | New Jersey | | |
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