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.
Redwood City, CA
- 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.
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.
- 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 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
Pearl Therapeutics is a privately held company focused on developing distinct combination therapies for the treatment of highly prevalent ch...