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- Responsible for supporting cGMP manufacturing activities including documentation and manufacture of clinical-grade biologics.
- Responsible for working with PD staff to modify existing "R&D" manufacturing processes and develop them for clinical-scale, cGMP-compliant manufacturing. This includes working with the project team on the transfer of processes into the cleanroom environment as well as helping generate relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures).
- With supervision, collaborate with Operations staff in the execution of the ongoing Environmental Control Program including facility cleaning and environmental monitoring (EM) procedures.
- Responsibilities include execution of the appropriate cleaning procedures for the facility and equipment as well as the execution and documentation of routine environmental monitoring tasks (total air particulates, air viable counts, viable counts from settling plates and viable counts from contact plates) and generation of written reports.
- Support Quality Assurance group by assisting in cGMP document control including Good Documentation Practices.
- Requires a High School Diploma (GED), Associate degree or a Program Certification from an accredited college or university
- Experience in a cGMP biologics manufacturing cleanroom environment is desirable.
- Knowledge of cGMP principles and Quality Management Systems is desirable.
- Familiarity of both upstream and downstream biomanufacturing processes is desirable.
- Familiarity of manufacturing processes in both mammalian and microbial systems is desirable.
- M-F: 8am-5pm
- Good interpersonal skills: ability to build strong relationships with cross-functional team members.
- Perform job responsibilities within all Standard Operating Procedures (SOPs) and policies.
- Ability to take responsibility and "get the job done" in a high-energy, high-intensity, results-oriented environment.
- Good verbal communication skills.
- PC skills with a knowledge base in Microsoft Word, Excel, Power Point.
Biomanufacturing Associate I, II, III - College Station, United States - MyKelly
Description
Biomanufacturing Associate I, II, III & IV (cGMP)Central Texas
Direct Hire Relocation Assistance
Day Shift
Kelly Science is currently recruiting for several Biomanufacturing Associates working in an FDA regulated environment. This role will provide cleanroom manufacturing support for the Biological Services Biomanufacturing Operations group. This entails execution of day-to-day cleanroom operations for specific manufacturing campaigns including preparing cleanrooms, materials and equipment for cGMP clinical-scale manufacturing as well as collaborating with project teams on the execution of production events.
In addition, this role will be responsible for collaborating with the Process Development (PD) team on the transfer of biologic processes from PD into Operations and into cleanroom manufacturing environments.
Job Responsibilities:
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