Sr. Manufacturing Technician, Drug Substance
7555 Gateway Boulevard Newark, CA 94560
The incumbent will be a part of the manufacturing organization and provide technical support in the areas of glassware/manufacturing parts washing, assembly of manufacturing accessories, solution preparation, inventory control of laboratory glassware and related manufacturing parts, and assist in manufacturing operations.
- Operation and routine maintenance of glass-washing equipment.
- Collection of dirty glassware and distribution of clean glassware to appropriate locations within the laboratories.
- Sterilization using an autoclave.
- Prepare solutions based on specifications and written procedures.
- Perform basic chemical/solution testing.
- Maintain safe and clean work environment and ensure compliance by following current GMPs and established internal control procedures.
- Cleaning and maintenance of laboratories.
- Distribution of appropriate gowning supplies to all locations within the manufacturing areas.
- Assist as required in cleaning of manufacturing equipment such as fementors, tangential flow filtration skids, and HPLC’ s.
- Document production by completing forms, logs, reports and records of equipment and batches.
- Update job knowledge by participating in training opportunities.
- Minimum 5 years of related industry experience or equivalent educational background.
- Skilled worker with at least 3 years of experience in pharmaceutical, biotechnology and/or sterile production, preferably in large-scale bacterial manufacturing environment.
- Experience with toxin manufacturing preferred.
- Experience in FDA regulated environments preferred.
- Minimum High school education or equivalency.
Preferred Additional Skills (i.e., Computer):
- Ability to work effectively in a team environment.
- Excellent communication skills.
- Ability to handle multiple projects at one time.
- Basic computer skills and proficiency with MS Word and Outlook preferred.