| Job Description | This is a full time process development position in a small fast-paced biotechnology company actively pursuing new and continuing clinical trials. The successful candidate will be responsible for the development of upstream processes for scalable production of viral vectors and gene delivery systems. The position will entail adaptation to scale of both established and novel viral vector production methods. In addition, the candidate will develop bioreactor technology for both attached mode and suspension cultures and utilize their experience to advance the project from bench scale to industrial-scale reactors in support of cGMP clinical viral vector production.
The position interfaces with a team of research scientists, regulatory specialists, and manufacturing operations management and will be instrumental in transferring the technology to a contract manufacturing organization or in-house pilot cGMP facility. Responsibilities will also include supporting Quality Assurance and Quality Compliance departments, scale-up functions in the research department, performance of IND-enabling studies, as well as audit functions within the company. Close interaction with members of the company team and adaptation to emerging needs are required. Finally, the position requires excellent written and verbal communication skills and the ability to work effectively in a dynamic team environment.
Job Requirements
•Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs and objectives in manufacturing from process development viewpoint.
•Address scale-up needs focusing on a bioreactor approach using both adherent and suspension cells.
•Carry out vector manufacturing process development and optimization, and participate in the production of virus-based gene transfer vectors to support clinical studies.
•Formulate and recommend Process Development policies and programs that guide the organization in maintaining and improving its competitive position.
•Help develop and optimize both research-grade and cGMP manufacturing methods, establishing procedures for improving the yield and purity of bench top viral vector production while maintaining high standards of manufacturing operations in order to ensure that products conform to established company quality standards for research, pre-clinical studies, and/or clinical trials.
•Contribute to the writing of standard operating procedures (SOPs) and implementation of documentation to support cGMP vector manufacture including the technology transfer reports.
•Ensure that all of the technical, logistical and regulatory aspects of the manufacturing processes can be planned and addressed in a timely manner.
•Provide a critical role and the technical lead in the transfer of the manufacturing process to a CMO.
•Support the QA/QC and audit function within the company.
EDUCATION and/or EXPERIENCE:
•A PhD or equivalent in the biological sciences with 2+ years biopharmaceutical / advanced therapies experience. Non-PhD candidates considered with extensive relevant experience.
•Knowledge of cGMP as applied to bioprocessing methodology and experience working in a pre-cGMP environment
•Prior practical experience of upstream and downstream process development; experience relevant to the production of viruses and proteins is especially valuable.
•Combine strong scientific and technological knowledge and skills relevant to our current and desired manufacturing methods, as implied by the above.
•Prior practical experience in quantitative purification using chromatography or density gradient ultracentrifugation.
•Proactive approach to solving problems.
•Project Management skills
•The ability to deliver and communicate results clearly and with adherence to deadlines.
•The ability to work closely with others as part of a team, while taking personal responsibility for assigned tasks.
•An accurate and systematic approach to the documentation of experimental work.
•The ability to learn new techniques and apply them to a high standard.
•Desirable skills include: ?Prior laboratory experience in molecular biology and quantitative PCR
?Prior laboratory experience with viruses and/or virus-like particles
?Previous practical experience in developing cell lines
?Capable of working in a clean room environment
?Experience with basic methods for characterization of viral vector methods, including SDS-PAGE analysis, PCR / QPCR, in vitro transduction assays, ELISA, and related assays
?Knowledge of standard immunological techniques such as ELISA, ELIspot and fluorescence flow cytometry |
| | Company | | Epeius Biotechnologies | Job Code | | State or Province | | California | | |
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