A member of the Process development and Manufacturing team manufacturing clinical trial material and assisting the process development team by producing process/product development materials.
Location
Redwood City, CA
Responsibilities
The principal objective of this position is to operate and maintain manufacturing equipment and maintain production readiness in the Redwood City Manufacturing Suite.
Execute particle manufacturing operations in cGMP facility at Pearl, including:
Operate feedstock preparation equipment
Operate spray dryer and perform collector change outs
Operate jet milling equipment and perform collector change outs
Sample product for release testing
Clean and maintain spray drying, feedstock preparation, and jet milling equipment
Dispense raw materials for manufacture
Maintain Redwood City Manufacturing Suite:
Conduct preventative maintenance activities, where appropriate
Assist in maintaining equipment records pertaining to PM and calibration activities, and equipment warranties
Communicate production successes and issues to Manufacturing and Process Development engineers and management to improve manufacturing operations
Suggest improvements to operations in GMP facility
Document production activities per Pearl SOPs and cGMPs
Monitor the environment of the GMP facility by following Pearl SOPs for airborne particles, room differential pressures, and sanitation
Maintain the inventory of consumables and supplies required for GMP production
Assist with activities outside the cGMP facility including:
Operate development spray dryers
Prepare and analyze powder and MDI samples
Participate in staff meetings and special project teams where required
Support Materials Management operations
Receive materials used in cGMP production
Package and ship cGMP materials to other Pearl facilities and contract manufacturing organizations
Assist in maintaining warehouse operation
Maintain a safe working environment
Observe and follow all safe operation practices
Routinely inspect facility safety equipment
Maintain a clean and clutter-free production environment.
Requirements
High School Diploma or Bachelor’s degree (Degree in sciences preferred)
3+ years of experience working in a pharmaceutical production facility with High School Diploma. Overall level of experience will determine position level
Good oral and written communication skills with an ability to work in cross-functional product development and manufacturing teams
Ability to conduct a wide range of manufacturing efforts in GLP, GMP and R&D contexts.
Pearl is an equal opportunity employer. We celebrate and seek to build upon the diversity of backgrounds reflected by our highly motivated, talented, and productive team.
Pearl offers its full time employees a competitive set of medical and other benefits.
Qualified applicants please submit your resume to Pearlofajob@PearlTherapeutics.com and include the job reference number listed on the job description.
Principals only, please.
Pearl Therapeutics Inc. - 30+ days ago
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