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Downstream Manufacturing Associate Jobs in California

Fladger Associates

Batch Record Coordinator

Fremont, CA · On-site

$21.25 - $29/hr

Ensures BioMES Electronic Batch Record (EBR) Modelers draft EBRs on-time for Downstream Manufacturing processing. * Maintains detailed Batch Record Delivery Schedule & Tracker for each product ...

Aequor

Manufacturing Specialist

Vacaville, CA · On-site

Manufacturing Associate Location: Vacaville, California Duration: 6 months+ Job Summary: Summary ... Downstream Manufacturing (DM) Responsibilities include the operation and cleaning of fixed tank ...

Ichor Systems

Manufacturing Supervisor

Fremont, CA · On-site

$99K - $169K/yr

Oversee saw operations to ensure materials are processed and delivered on schedule to downstream ... Associate's degree or technical certification in Manufacturing, Engineering, or related field.

Ichor Systems

Manufacturing Supervisor

Fremont, CA

$99K - $169K/yr

Associate's degree or technical certification in Manufacturing, Engineering, or related field ... Oversee saw operations to ensure materials are processed and delivered on schedule to downstream ...

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All JobsDownstream Manufacturing Associate JobsDownstream Manufacturing Associate Jobs in California

Downstream Manufacturing Associate information

What is a downstream manufacturing associate?

Downstream Manufacturing Associates are professionals who work in the later stages of biopharmaceutical and biotechnology manufacturing processes. Their main responsibilities involve purifying and processing biological products after the initial production phase, often using techniques like filtration and chromatography. They ensure the quality and safety of the final product by following strict protocols and maintaining detailed documentation. Downstream associates often work in cleanroom environments and collaborate with other teams to meet production goals.

What are the key skills and qualifications needed to thrive as a downstream manufacturing associate?

To thrive as a Downstream Manufacturing Associate, you need a solid understanding of bioprocessing, protein purification, and GMP (Good Manufacturing Practice) standards, often gained through a degree in life sciences or related field. Familiarity with chromatography systems, filtration technologies, and process automation tools is typically required, alongside relevant safety certifications. Attention to detail, teamwork, and strong problem-solving skills are valued soft skills in this role. These qualifications are essential for ensuring the efficient, safe, and compliant production of biopharmaceutical products.

What are some typical challenges faced by downstream manufacturing associates, and how can they be addressed?

Downstream Manufacturing Associates often encounter challenges such as maintaining strict adherence to GMP (Good Manufacturing Practices), troubleshooting equipment issues, and ensuring consistent product quality during purification and filtration processes. These challenges can be addressed through thorough training, clear documentation, and effective communication within the team. Collaborating closely with upstream teams and quality control helps resolve issues quickly and ensures smooth workflow. Staying detail-oriented and proactive in identifying potential bottlenecks also contributes to success in this role.

What is the difference between Downstream Manufacturing Associate vs Upstream Manufacturing Associate?

AspectDownstream Manufacturing AssociateUpstream Manufacturing Associate
Primary ResponsibilitiesPurifies, filters, and processes final product batchesPrepares raw materials and manages initial production stages
Work EnvironmentCleanroom, laboratory, manufacturing floorManufacturing plant, laboratory, production line
Required CertificationsGMP training, OSHA safety certificationsGMP training, OSHA safety certifications
Industry UsagePharmaceutical, biotech manufacturingPharmaceutical, biotech manufacturing

Downstream Manufacturing Associates focus on final product purification and processing, while Upstream Manufacturing Associates handle raw material preparation and initial production. Both roles are essential in biopharmaceutical manufacturing, often requiring similar certifications and working in related environments.

What cities in California are hiring for Downstream Manufacturing Associate jobs?

Cities in California with the most Downstream Manufacturing Associate job openings:

Manufacturing Associate - Biotech - Vacaville, CA

Vacaville, CA • On-site

Unicon Pharma Inc.
Recruiting and Staffing Services • 11 - 50 employees
Learn more about Unicon Pharma Inc.external

Contractor

Re-posted 10 days ago

Job description

Description:
Shifts and Hours schedule:
Upstream Day Shift: 6am - 7pm
Upstream Night Shift: 6pm - 7am
Downstream Day Shift: 6:30am - 7:30pm
Downstream Night Shift: 6:30pm - 7:30am

  • These roles follow a 3-4-3 shift pattern

Role Purpose:

  • The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions.
  • Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment.
  • They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
  • 40% Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate
  • 20% Attain qualification for all assigned tasks and maintain individual training plan
  • 10% Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
  • 10% Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
  • 10% Maintain facility and equipment through routine cleaning and sanitization, support 6S programs
  • 10% Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.
  • High School Diploma or Equivalent minimum; AS/BS preferred
  • Preferred area of study: Science related discipline
  • 0-3 years’ experience; some prior experience in a manufacturing setting preferred.
  • Proven logic and decision making abilities, critical thinking skills