Job Description

The GMP Manufacturing Technician position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements at the Petaluma and Novato ISO 13485 sites and as directed by the GMP Manufacturing Management.

This will be in our Kit Lab in Novato. Techs do final dry down (lyophilizatoin), column packing for purification, aliquoting and kitting of product.

Shift: Monday-Friday, 5 x 8 hours, 0600-1430.

• Perform manufacturing activities according to written protocols, as directed by the departmental supervisor, manager or director.
• Maintain batch records, equipment logs and other production records as directed per company procedures.
• Follow current Good Manufacturing Practices (cGMP) and close adherence to internal SOPs utilizing GDP practices.
• Perform routine operation, maintenance, inspection and cleaning of equipment in accordance with operational instructions
• Quick and effective diagnosis of routine problems in manufacturing steps
• Initiate attention to operators and tag-outs per documented processes
• Execute Deviation and Nonconformance action plans
• Reporting of safety incidents or safety hazards to senior colleagues, supervisors or managers
• Maintain a clean an orderly laboratory environment.

Qualifications

• Bachelor's degree in a related STEM field is required.
• 1 year of equivalent industry lab experience and training and/or demonstration of ability to meet the requirements of a GMP Technician.
• Knowledge of HPLC, MS, Purifiers, Spectramax, SpeedVacs, Liquid Handlers, TFF, Pipettes, experience or knowledge preferred.
• Ability to add, subtract, multiply, and divide all units of measure, using whole numbers, common fractions, and decimals.
• Microsoft Office, Outlook, Word, and Excel, use of a web browser – Unicorn and Empower a plus.
• Self-motivated with the ability to work independently as well as on teams
• Professional presence and strong attention to detail is required
• Technical proficiency that enables effective execution of documented procedures
• Able to multi-task work in a fast-paced environment.
• Strong communication and problem solving abilities are necessary.

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

The typical pay range for this role is:

Minimum: $ 20.91/ Hourly

Maximum: $ 34.855/ Hourly

This range represents the low and high end of the anticipated salary range for the California -based position. The actual base salary will depend on several factors such as: experience, skills, and location.