BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for an Upstream Director to work for a leading San Diego biotechnology company.
As a member of the senior management team, this individual will be involved in the production and processing of recombinant proteins for clinical use.
- Manage a complex workload for cell line development, upstream process development, and upstream manufacturing activities.
- Responsible for leading a team of supervisors and technicians.
- Provide support to cross-functional teams to meet production or timeline demands.
- Demonstrate understanding and provide oversight on technical operations, safety, and Good Manufacturing Practice.
- Provide oversight on upstream processes as well as clean-room facility and equipment operations.
- Develop staff capabilities, creating a culture of safety, maintain training objectives, compliance and collaboration while implementing process improvements where applicable
- Initiate, review, and revise cGMP Batch Production Records, SOP’s, Process Development reports, and Manufacturing Summary reports.
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
- Expert in cell line development, upstream process development and upstream manufacturing processes
- PhD’s degree in Life Sciences or Chemical Engineering with more than 7 years of relevant experience in GMP production including aseptic processing, or a BS/MS degree in Life Sciences or Chemical Engineering with more than 15 years of relevant experience.
- More than 5 years of supervisory experience
- Practical Experience with cGMP operations.
- Must be proficient in Word and Excel.