University of Rochester Technical Assoc I (S) in Rochester, New York
Full Time 40 hours Grade 051 Microbiology & Immunology M&D;
8 AM-4:30 PM; OCC WKENDS/HOL
Provide ongoing support of the Upstate Stem Cell cGMP Facility (USCGF) including technology transfer, cGMP process and analytical development, and GMP production and testing of therapy products.
Under the general guidance of the Facility Director, with latitude for exercising independent technical judgment, specific responsibilities will include:
- Assist in establishing and maintaining SOP’s. Participate in all technology transfer and cGMP process development for processes and analytical tests by working closely with faculty, staff, and students from collaborating laboratories.Collaborating laboratories will transfer processes and analytical test methods to the USCGF for further clinical scale development and validation.Following cGMP-approved technology transfer protocols, the Technical Associate I will modify existing research manufacturing process and analytical methods for clinical-scale GMP purposes.Generate all relevant documentation with meticulous detail (e.g., Batch Records, Compounding Records, Test Methods, Operating Procedures).
- Assist with all aspects of tissue culture, including hands-on work with stem cells and developing cell differentiation protocols and cell-based assays. Clean, sterilize, and maintain equipment and the facility. Set up and operate equipment (e.g., microscopes, biosafety cabinets, centrifuges).
- Be involved in the generation, evaluation, and testing of cGMP batches of therapy products to be used in clinical trials. Actively participate in the quality system maintenance implemented at the facility.
- Collaborate with cGMP staff in execution of ongoing environmental monitoring program. This includes compilation and analyses of data (total air particulates, air viable counts, viable counts from settling plates, and viable counts from contact plates) and generation of written reports that will stand up to FDA audits.In cases of non-compliance, make recommendation for necessary changes to reach compliance and bring to the attention of the Director.
- Bachelor’s degree with major course work in field of assignment and 1 year of related work experience involving direct assistance to researchers; or any equivalent combination of experience, training and education.The ideal candidate will have a BS or MS degree in a biological discipline and 2+ years of experience in laboratory research.
- Hands-on cell culture experience and a strong understanding of biochemistry and cell and molecular biology are required.
- Experience in chromatography and flow cytometery is preferred.
- A strong background in cGMP principles and Quality Management Systems is highly desirable. Applicants should be well-organized, self-motivated, and capable of working both independently and as part of a team.
- Strong analytical, written and oral communication, and computer skills with the ability and desire to readily learn new experimental techniques.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Technical Assoc I (S)
Location: School of Medicine & Dentistry
Job ID: 204063
Full/Part Time: Full-Time