Manufacturing Associate
Planet Pharma
Date: 1 day ago
City: Novato, CA
Contract type: Full time
Job Description
PROCESS KNOWLEDGE:
Understanding of process theory and equipment operation.
Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with a broad understanding of scientific, compliance, and technical components
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated experience with automation systems (LIMS, MES, PI, etc.)
Technical Documentation
Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents
Quality And Compliance
Understanding of cGMPs as related to Clinical and/or Commercial Operations
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
Business
Ability to participate on projects and contribute to outcomes
Capability to learn and support new business systems (Track wise, ERP, etc.)
Support trending of defined department metrics
Other duties as assigned.
Key Qualifications/Must-haves (please any information that is not included in the provided job description): Communicaiton skills, Computer literacy/typing skills and good legible documentation/handwriting skills are required.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
PROCESS KNOWLEDGE:
Understanding of process theory and equipment operation.
Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with a broad understanding of scientific, compliance, and technical components
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated experience with automation systems (LIMS, MES, PI, etc.)
Technical Documentation
Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents
Quality And Compliance
Understanding of cGMPs as related to Clinical and/or Commercial Operations
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
Business
Ability to participate on projects and contribute to outcomes
Capability to learn and support new business systems (Track wise, ERP, etc.)
Support trending of defined department metrics
Other duties as assigned.
Key Qualifications/Must-haves (please any information that is not included in the provided job description): Communicaiton skills, Computer literacy/typing skills and good legible documentation/handwriting skills are required.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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