Scientist I
Encontrado en: beBee S PE - hace 3 semanas
Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
The Scientist will be working at Process Development department of Biologics CMC located at West Chester, Pennsylvania as an upstream (cell culture) process development lead for delivering robust cell culture processes for novel biologics and biosimilar molecules. The Scientist will manage a group of associates and work closely with other functional teams to meet the project deliverables and timelines. He/she will be acting as an SME (subject matter expert) of cell culture process development for refining and delivering platform solutions to advance Teva’s pipeline of biopharmaceutical products.
Responsibilities will include, but will not be limited to, technology trasfer to internal and external manufacturing sites, leading technical meeting with cross functional teams and manufacturing sites, execution of fed-batch cell culture process development, design of experiments to drive process understanding, process characterization, and developing process control strategies from early-stage development through commercial launch.
Other duties include
- Author internal technical protocols, reports and support CMC documentation for regulatory filing (IND, BLA, MAA)
- Responsible for technology transfer for assigned projects from internal and /or external manufacturing sites
- Provide technical support to resolve manufacturing issues as an upstream SME
- Independently design and perform cell culture process development studies on monoclonal antibody expression in CHO cell lines at bench scale and/or pilot scale, using engineering principles
- Manage associates working on cell culture process development, characterization, validation for multiple projects at various development stages.
- Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies
Required Qualifications:
- PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or other related science/ engineering field with minimum 0 years of experience, or Master’s degree with minimum 10 years of experience, or Bachelor’s degree with minimum 12 years of experience in biopharmaceutical/biotech industry
- Experience in technology transfer, authoring technical documents, design and execution of studies for cell culture process development.
Preferred Qualifications:
- Experience in technology transfer, authoring technical documentation and regulatory filing
- Experience in cell culture process development, process characterization, and Process Performance Qualification (PPQ).
- In depth understanding of monoclonal antibody manufacturing processes
- Hands-on experience in laboratory and/or pilot scale cell culture and harvest systems, including but not limited to Ambr 250, bench scale, and pilot scale bioreactors.
- Proficiency in process data analysis using statistical models and statistical software JMP
- Well versed in literatures, patent landscape, and regulatory guidelines on biopharmaceutical production
- Good understanding of cGMP principles, and how they are related to process development of biopharmaceuticals.
- Excellent verbal and written communication skills
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