Yoh Life Sciences is seeking a Manufacturing Associate to support our Gene Cell Therapy client in the San Francisco Bay Area. The candidate will demonstrate expertise and breadth of knowledge in executing processes across a variety of production activities such as cell processing/purification, aseptic behavior, monitoring equipment and processes, product sampling, and conducting routine sanitization tasks to maintain facility and equipment. You will read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify, and communicate non-routine events, and review more complex decisions with your direct supervisor.

Industry: Gene Cell Therapy
Location: San Francisco Bay Area
Type: Direct Hire

Responsibilities:

• Oversee and participate in the execution of viral vector manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment
• Operate and troubleshoot process equipment such as TFF skids, incubators, functionally closed system bioreactors, and controlled rate freezers
• Buffer preparation
• With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training
• Troubleshoot OOE and OOT issues during routine manufacturing
• Manage, provide guidance, and support a team of manufacturing associates
• Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM
• Must possess high degree of learning agility
• Support Quality Management system including but not limited to deviation investigations and risk assessments
• Understand and implement safety procedures

Qualifications:

• Bachelor’s degree in a biological science, engineering or related science discipline with 1 – 3 years of experience in a clinical processing and/or cell culture/purification operations preferably in a GMP environment; or equivalent combination of education and experience.
• GMP experience in a cleanroom for cell therapy products required with previous experience in gown qualification, aseptic behavior, materials kitting, and aseptic flow of materials
• A strong background in cell culture and/or purification
• Buffer preparation knowledge
• Working knowledge and understanding of GMP, GCP, GDP, and relevant FDA guidelines.
• Process-oriented with strong analytical skills for risk identification and management.
• Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software

Any pay ranges displayed are estimations which may have been provided by job boards. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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