A member of the Process Development and Manufacturing team developing pilot to commercial scale manufacturing processes and assisting the manufacturing team during manufacturing campaigns and other periods of increased workload.
Redwood City, CA
- The principal objective of this position is to support the process development and manufacturing team by conducting process studies, maintaining equipment & facilities, and participating in manufacturing activities when required.
- Execute particle manufacturing process development studies in the Redwood City Manufacturing Suite at Pearl, including:
- Assist in design of process development studies
- Coordinate development studies with manufacturing schedule
- Participate in production of test material during process development study execution
- Compile & analyze data, document results, and review manufacturing documentation
- Present study results to process development team and summarize for the product development team
- Maintain pilot plant:
- Assist in tracking and coordinating preventative maintenance and calibration activities
- Assist in maintaining equipment records pertaining to PM and calibration activities, and equipment warranties
- Assist in maintaining secured spare parts storage and stock inventory of spare parts for pilot plant equipment
- Support manufacturing operations in the pilot plant:
- Draft production protocols, master batch records, and standard operating procedures
- Participate in production of materials for clinical trials and toxicology studies
- Review completed batch production records, production protocols, and laboratory notebook studies for completeness and technical accuracy
- 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.
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.
- Bachelor’s degree in Engineering: chemical and mechanical engineering degrees preferred
- 0-2 years experience working in a pharmaceutical production facility
- Good oral and written communication skills with an ability to work in cross-functional product development and manufacturing teams
- Experience with cGMP requirements and clean room operations is a plus.
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.