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Biomanufacturing Operations Technician

Operations Technician Department: Biomanufacturing

General Summary
Reporting into the Operations Manager, this person will provide cleanroom manufacturing support for the Scorpion 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 person 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.
Strict attention to detail, high quality customer service skills and the ability to instill these qualities onto others on the team.

Key Responsibilities
·      With supervision, following FDA or appropriate global regulations and guidelines, this individual will support cGMP manufacturing activities including documentation and manufacture of clinical-grade biologics.
·      With supervision, collaborate on process transfer from Scorpion’s Process Development (PD) group and/or external client teams. 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.
·      With supervision, support Quality Assurance group by assisting in cGMP document control including Good Documentation Practices.

Education & Experience
·      Requires an Associate degree or a Program Certification from an accredited college or university with major course work in Biotechnology.
·      Experience in a cGMP biologics manufacturing cleanroom environment is desirable.
·      Experience in cGMP principles and Quality Management Systems is desirable.

Knowledge & Skills
·      Familiarity with both upstream and downstream biomanufacturing processes is desirable.
·      Familiarity of manufacturing processes in both mammalian and microbial systems is desirable.
·      Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
·      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.