GID Technician

Job Summary and Purpose

The primary responsibility is to assist in the industrial development, process, and product improvement of viral, bacterial, parasitic and/or recombinant vaccines.

Responsibilities and Key Duties

• Development & Process Transfer Sub-Family

• Industrialization Strategy Definition and Management

• Develop state-of-the-art, robust, and cost-effective biological production processes from laboratory to industrial scale

• Batch Manufacturing Preparation

• Risk Assessments

• Process Improvement

• Carry out the dedicated laboratory activities in process improvement

• Write process related study protocols, reports, SOP’s and manufacturing directions

• Support QC assay transfer as well as optimization & trouble shoot activities

• Carry out the dedicated laboratory activities in technology transfer processes

• Training & Tech Transfer

• Supports the transfer of processes into Industrial Operations

• Assists in designing/leading training sessions for production operators

• Writes technical transfer draft report

• Production & RD Support

• Laboratory work as assigned on viral, bacterial, parasitic and/or recombinant vaccine projects

• Lab Management

• Ensures labs preventive maintenance & qualification

• Updates user guides / protocols for GID

• Internal audit & Inspection

• Updates and writes instructions and forms according to relevant quality standards

• Provides inputs to answer internal/external audit & inspections queries

• Participates in the trials plans proposal and execution to be performed for change control activities

• Provides inputs for concerned change control processes led by QA

• Suggests the improvement of industrial lab practices

Core Competencies

• Entrepreneur: Drive ambition and accountability – shows concern for reaching targets

• Work Together: Collaborate with empathy – Responds to cooperation requests

• Work Together: Engage and develop – Values learning for oneself and others

• Work Smarter: Shape solutions out of complexity – Accepts needs for flexibility

• Work Smarter: Client focus – Responds appropriately for needs and requests

Qualifications

• Education – BA/BS in Microbiology, Biology or Chemistry/Pharmacology or related fields required

• Work Experience – 2+ years of work experience in aseptic processing, fermentation, cell culture, and assays in research and/or manufacturing environment is strongly preferred

• Other – Basic knowledge in Microbiology and Chemistry, tissue culture, and virus titration or prior virology experience a plus