Manufacturing Associate/Sr. Manufacturing Associate

Job Code SC22011

General Summary

This person will be responsible for supporting the manufacture of stem cell derived products. This person will be responsible for directly producing in-house material for research as well as coordinating production activities at Contract Manufacturing and Testing Sites.

This position requires maintaining thorough documentation and performing laboratory activities in accordance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).

Principal Duties and Responsibilities

• Coordinates activities supporting manufacturing from scheduling, ordering of raw materials, production, through to lot release.
• Coordinates storage, shipment, and inventory control of finished product at various sites.
• Develops, writes, and revises SOPs for manufacturing
• Reviews completed batch records for accuracy
• Investigates deviations and proposes corrective actions
• Performs data analysis, maintains productions metrics, and writes reports.
• Transfers manufacturing technology and methods as required to contract sites.
• Participates in training clinical personnel on the handling of product.
• Participates in impact analysis of deviations as required.
• Assists with maintaining laboratories (equipment maintenance, calibration, cleaning and related documentation) in accordance to GLP and cGMP.
• Performs activities, as needed, in accordance with Good Laboratory Practices and current Good Manufacturing Practices.
• Presents data at departmental meetings, maintains notebooks and electronic files associated with each experiment and contributes to the preparation of final experimental reports.
• May serve as person-in-plant at Contract Manufacturing Organizations; approximately 10% travel required.

Qualifications

• B.S. in biological sciences or related discipline with a minimum of 4 years of industrial experience.
• Extensive manufacturing experience in cGMP and clean room environments
• Experience in mammalian cell culture and one or more of the following disciplines; raw material sourcing, fill and finish, or cold chain shipping.
• Demonstrated ability to accurately follow written procedures and maintain detailed documentation.
• Experience with flow cytometry highly desired.
• Excellent computer, organizational, written and verbal communication skills
• Strong troubleshooting skills
• Strong ability to multi-task and prioritize work with limited guidance
• Attention to detail with mastery of cGMP and GLP requirements.
• Must be a team player and be able to work in a multi-disciplinary team.

Cellerant is an Equal Opportunity Employer, committed to hiring the best qualified individuals and giving them the opportunity to stretch their abilities. We offer a competitive compensation and benefits package. Please submit your CV and cover letter by Mail/Fax or Email including job code SC22011 in subject line to hr@cellerant.com.

Contact

Cellerant Therapeutics, Inc.
Human Resources – Job Code: SC22011
1561 Industrial Rd
San Carlos, CA 94070
Tel.: 650-232-2122
Fax: 650-232-5495