Drug Product Manufacturing Associate I
Argonaut Manufacturing Services
Summary
The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing. This role is 100% On-Site, Monday - Friday, 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.
Job description
Position Overview
The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing. This role is 100% On-Site, Monday - Friday, 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.
Duties and Responsibilities
- Perform various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines
- Prepare material components for manufacturing operations
- Document steps clearly and completely in production batch records, logbooks and other controlled forms
- Participate in inspection readiness activities
- Perform basic arithmetic and algebraic computation
- Maintain cleanliness of areas and equipment
- Assist senior level personnel in bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc., gowned in accordance with Class C (ISO 7) conditions
- Assist senior level personnel in sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions
- Assist senior level personnel in sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions
- Collect and dispose of lab wastes according to established procedures
- Collaborate in continuous improvement activities
Education and Experience Requirements
- High school diploma or equivalent with 1 - 2 years relevant experience is required, a Bachelor's in an Engineering discipline or Life Science field preferred
- Time and project management skills with the ability to multi-task are essential
- Must be able to effectively communicate within department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
- Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business, is a plus
Requirements
- High school diploma or equivalent
- 1 - 2 years relevant experience
- Bachelor's in an Engineering discipline or Life Science field preferred
- Time and project management skills with the ability to multi-task
- Must be able to effectively communicate within department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic
- Ability to work independently with minimal direction
- Experience in a growth-oriented, cGMP contract manufacturing organization is a plus
Benefits
- Medical, Dental & Vision
- Company-Paid Life Insurance
- Voluntary Life Insurance
- Short-Term Disability
- Long-Term Disability
- FSA & HSA
- 401(k) Matching
- 10 Days PTO
- 10 Paid Holidays
Company overview
Argonaut Manufacturing Services is a leading contract development and manufacturing organization (CDMO) specializing in life sciences, molecular diagnostics, and biopharmaceutical manufacturing. Founded in 2016 and headquartered in Carlsbad, California, the company operates across five state-of-the-art facilities totaling over 100,000 square feet of manufacturing space. Argonaut provides comprehensive services including aseptic drug product manufacturing, lyophilization, analytical services, and IVD (in vitro diagnostics) manufacturing. The company has produced more than 4.2 million diagnostic kits since its inception and serves over 131 projects across the pharmaceutical, diagnostic, and life science sectors. With a team of industry veterans from organizations like Thermo Fisher, Affymetrix, and Allergan, Argonaut offers specialized expertise in complex formulations, terminal sterilization, and regulatory compliance. The company recently expanded its capabilities with a new sterile fill-finish facility capable of handling up to 100,000 vials per batch, positioning it to support clients from clinical trials through commercial manufacturing. Argonaut maintains ISO 13485:2016 certification, cGMP compliance, and FDA registration, emphasizing its commitment to quality and regulatory excellence in contract manufacturing services.