732-661-0400

Lead Manufacturing Technician

  • Location: Novato
  • Type: Contract To Hire
  • Job #36378

Our Biotechnology client in Sonoma County is in search of a GMP Manufacturing Technical Lead who is responsible for working directly with the departmental Supervisor and Manager to ensure that all respective functions of that department in the GMP Manufacturing Lab are performed in compliance with company procedures and external regulatory requirements.

Hours: Fri – Sun 12 hr days 

Essential Functions

  • Conscientiously learns requirements of the ISO 13485 quality management system and diligently follows the terms of a quality contract.
  • Perform and or support the respective functions and tasks of that department for GMP oligonucleotides according to established procedures.
  • Capable of operating and manufacturing product on all instruments in immediate work area.
  • Makes decisions – guided by policies and procedures – that impact the group’s ability to meet performance objectives
  • Use tracking and reporting systems, drive performance and assure timely completion of product and process quality
  • Recognize any issues from the equipment and any affiliated documentations and take appropriate corrective action within scope
  • Lead training activities, oversee training and adherence to standard operating procedures (SOPs)
  • Provides technical guidance to team members
  • Assist with the creation and review or manufacturing procedures and documentation used in the GMP manufacturing lab.
  • Initiates and executes quality system documentation, including Deviation and Nonconformance Reports, Customer Notifications, Change Request Records, etc.
  • Responsible for the safe use of hazardous chemicals in a manufacturing environment daily and adherence to the company Personal Protection Equipment (PPE) policy
  • Maintain training up to date.
  • Travel Requirements – no travel required.
  • Schedule/Core Hours – are based upon the Production Lab and Shift, these will be detailed below with potential for overtime hours as the workload requires and with manager’s pre-approval.
  • Adherence to company Personal Protection Equipment (PPE) policy.

Qualifications: 

  • Bachelor’s degree in a related field or 2+ years of equivalent industry experience and training and/or demonstration of ability to meet the requirements of a GMP Technician
  • 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
  • Microsoft Office, Outlook, Word, and Excel, use of a web browser – Unicorn and Empower a plus.
  • Technical proficiency that enables effective execution of documented procedures
  • Demonstrated experience with common computer software packages (Windows, MS Office, )
  • Able to multi-task work in a fast-paced
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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