Process Development Technician
* Process Development | Large Molecules
* Greater Houston Area
* $80,000-90,000 + Competitive Benefits Package
An industry-leading biotechnology firm focused on immunotherapies is looking to hire a manufacturing technician who will work closely with the Senior Director of CMC. This person will be tasked, depending on prior qualifications and experiences, to either lead or contribute to the team responsible with advancing the therapeutic programs' manufacturing processes and characterizations. The ideal candidate should have experience working in a collaborative environment and should be able to effectively communicate within an interdisciplinary environment. The ideal candidate will also demonstrate the ability to work independently and under minimal supervision.
General and Technical:
* Demonstrated ability to work as a collaborative member of a project team and an ability to communicate effectively with colleagues.
* Strong understanding of GTP, GMP, and GLP guidelines.
* Strong working knowledge of aseptic techniques, cell culture techniques, bioanalytical assays, and an understanding of basic cellular biology
* Working knowledge of the scientific and technical aspects of T-cell culture is desirable
* Effective oral and written communication skills.
* Ability to work well under pressure and meet critical timelines.
* Demonstrated knowledge and application of industry relevant computer programs, as well as working knowledge of MS Office programs (e.g. Excel, Word).
* Must be able to observe and assess assay results
* Perform procedures, such as cell isolation or enrichment, culture, cryopreservation and cell product thaw/wash.
* Conduct accurate calculations to determine cell viability, dilutions, and cell concentrations.
* Demonstrate ability to identify issues and subsequently construct novel solutions to solve them.
* Implement and maintain compliance procedures regarding quality and safety systems.
* Provide regular updates, data, and applicable documentation to the project team.
* Complete procedures and the accurate documentation in compliance with Good Laboratory Practices as well as familiarity with Good Manufacturing Practices.
* Participate in the preparation of CMC sections for regulatory submissions, invention disclosures, progress reports, and publications.
* Communicate research and development findings with internal and external partners.
Minimal Experience and Skills:
* BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
* Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
* Expertise in process development and process characterization of scale-up/scale-down cell manufacturing processes.
* Cell culture experience is essential.
* Experience with T cell-based therapies preferred.
* Attention to detail, problem-solving abilities, workflow and deadline management, and ability to work on a fast-paced team environment required.