Manufacturing Technician II, Lyophilization

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 34,000 - 37,000; Full time

Job summary

Argonaut Manufacturing Services Inc. seeks a Manufacturing Technician II - Lyophilization to execute production processes in a cGMP/compliant, ISO-clean environment at our Carlsbad site. You will organize the lyophilization group and support other departments while performing hands-on manufacturing tasks.

The role focuses on lyophilized product formation, documentation, and adherence to safety procedures. On-site work schedule is Monday–Friday with possible overtime and start times as early as

Qualifications

• Requires a bachelor's degree in a related field and at least 1 year of work experience at Argonaut or in similar/related industry; or high school diploma with 3 years' related work experience.
• 1 or more years' experience in Contract Manufacturing
• 3 or more years' experience in Formulations or Lab Bench
• 3 or more years' experience in pH/Balance/Pipette
• 5 or more years' experience in a GMP environment
• Must be punctual and maintain attendance.
• Excellent problem-solving skills and the ability to make critical decisions accordingly.
• Proven attention to detail
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Must be able to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.
• Understands Manufacturing Production Processes as it pertains to product integrity processes.
• Knowledge of chemical and biological safety procedures.
• Knowledge of Formulation/Lyophilization operations and capabilities.
• Basic knowledge of microbiology and clean room workflows including aseptic technique

Responsibilities

• Adhere to ISO 13485 and cGMP production environment and quality system requirements.
• Operate in a multifaceted laboratory environment on projects with varying complexity and cross-functional teams.
• Prepare and review documentation per cGMP and cGDP procedures; update records after manufacturing.
• Support pilot manufacturing and sustaining projects within cGMP workflows using SOPs.
• Formulate liquids, fill liquids, and create lyophilized products in an ISO cleanroom.
• Handle liquid nitrogen per OSHA guidelines and manage heavy Dewars safely.
• Visually inspect lyophilized and liquid products for quality.
• Perform basic arithmetic for volumes and concentrations.
• Perform unit conversions for gravimetric and volumetric measurements.
• Operate pipettes, balances, centrifuges, pH meters, and heat sealers.
• Perform biodecontamination and maintain sterile production areas.
• Author Non-Conformance Reports (NCR) and risk analysis memos.
• May perform other duties as assigned.
• Duties may evolve with business needs.

Skills

Punctuality

Problem solving

Attention to detail

Communication (verbal/written)

English reading/writing

Education

Bachelor's degree in related field

High school diploma + 3 years related experience

Tools

Pipette

pH meter

Centrifuge

Analytical balance

Job description

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Position Type & Pay Range

This position is initially offered as a temporary assignment with the potential to transition to a regular, full-time position based on business needs and performance. The intent is for this to be a temp-to-hire opportunity.

The pay range for this position is between $25.00 - $27.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Position Overview

The Manufacturing Technician II - Lyophilization is responsible for executing all production processes while strictly adhering to cGMP, environmental health and safety guidelines, and any other applicable regulations. Under the general direction of the lead technician and overall supervision of the supervisor, this position is responsible for the hands-on execution of all activities in the production area.

Additionally, this role plays a key part in manufacturing lyophilized products, organizing the lyophilization group within the Life Sciences Department, and supporting other departments and groups as needed. The Senior Laboratory Technician is expected to fully participate in departmental projects and quality working teams as applicable. All specific requirements outlined in this job description apply to the functional area in which it resides.

This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time is 6:00 am with a consistent schedule.

Duties and Responsibilities

• Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with our quality system.
• This role works in a multifaceted laboratory environment executing projects of low-high complexity and criticality with multi-functional teams.
• Execute documentation based on cGMP and cGDP procedures, as well as perform documentation review post manufacturing execution.
• Support pilot manufacturing of new project introductions and sustaining projects within cGMP workflows utilizing SOPs.
• Responsible for formulation of liquid components, filling of various liquids, and creating lyophilized product in an ISO cleanroom environment.
• Handling of liquid nitrogen according to OSHA safety guidelines and lifting of heavy liquid nitrogen Dewars using proper body mechanics.
• Visual inspection of lyophilized product and liquid product.
• Perform basic-intermediate arithmetic calculations as it pertains to total volume and liquid concentrations.
• Perform daily unit conversions as it pertains to gravimetric and volumetric measurements utilizing the metric system.
• Operate laboratory equipment such as pipettes, balances, centrifuges, pH meters and heat sealers.
• Responsible for Biodecontamination (cleaning, sanitization, etc.) and appearance of all formulation and lyophilization production areas.
• Author Non-Conformance Reports (NCR) and risk analysis memos.
• May perform other duties as assigned.
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Education and Experience Requirements

• Requires a bachelor's degree in a related field and at least 1 year of work experience at Argonaut or in similar/related industry; or high school diploma with 3 years' related work experience.
• 1 or more years' experience in Contract Manufacturing
• 3 or more years' experience in Formulations or Lab Bench
• 3 or more years' experience in pH/Balance/Pipette
• 5 or more years' experience in a GMP environment
• Must be punctual and maintain attendance.
• Excellent problem-solving skills and the ability to make critical decisions accordingly.
• Proven attention to detail
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Must be able to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.
• Understands Manufacturing Production Processes as it pertains to product integrity processes.
• Knowledge of chemical and biological safety procedures.
• Knowledge of Formulation/Lyophilization operations and capabilities.
• Basic knowledge of microbiology and clean room workflows including aseptic technique

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.