Fremont, CA

A quickly growing CDMO is seeking an experienced Process Development Scientist to join the team!

This Jobot Job is hosted by: Amber Basinger
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $110,000 per year

A bit about us:

A biologics contract development and manufacturing organization that creates recombinant protein products!

Why join us?

We offer an excellent benefits package that has been designed to meet the needs of our diverse workforce. Our package provides employees a consistent, competitive level of benefits with the flexibility to support individual growth within the organization.

Medical, Dental, Vision
401k
Employee Stock Purchase Plan
Paid Time Off & Paid Holidays
Training Programs
Casual Work Environment
Short and Long-Term Disability
Employee Assistance Program

Job Details

Essential Duties and Responsibilities:

• Executes, with oversight of qualified staff, complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.
• Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.
• Maintains own training within compliance.
• Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities.
• Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, SOPs, and regulatory filing documents per project needs.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify managers of any issues and discrepancies immediately.
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
• Collaborate with other departments for raw materials, water, testing requirements, documentation, maintenance, and scheduling
• Other duties as assigned to ensure appropriate compounding practices

Qualifications

• BS in Engineering, Life Sciences, or related discipline with 1-2 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Must have bioreactor operations experience.
• Understanding of mammalian cell culture performance is required.
• Experience with perfusion bioreactors, Ambr15 or Ambr 250 a plus.
• Creative thinker that can identify better and more efficient methods to address issues and gaps
• Demonstrate ability to work independently and on cross-functional teams.
• Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
• Strong analytical skills and attention to detail.
• Effective verbal and written communication skills
• Must be able to work independently as well as work with a diverse team.
• Ability to prioritize assignments and to manage multiple projects simultaneously.
• Flexible mindset for a dynamic environment.
• Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.