Bio-Manufacturing Associate I-III- 2nd Shift

Position:

Manufacturing Associate I-III Class:

Non-Exempt Reports to:

Manufacturing Managers Location:

West Sacramento, CA Company Profile Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics. The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows

• regardless of batch size.

Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. GeminiBio is an

ISO 13485

certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820. Position Summary The Manufacturing Associate will work within the Manufacturing Department and be responsible for daily execution of tasks associated with the manufacture of products produced by GeminiBio in accordance with cGMPs. Our products are made aseptically and are sterile-filled following cGMPs. In addition, this person may be asked to assist, and/or perform tasks outside of direct product manufacturing, such as cleaning the manufacturing spaces or to execute maintenance, calibration or validation protocols. This person will be expected to follow, and at times write and implement standard operating procedures (SOPs), work instructions (WIs) and device history records (DHRs) following FDA, USDA, and/or other applicable international guidance documents. This person will always be expected to collaborate as a team player with personnel in EHS, Engineering, Supply Chain, QC, QA and Development to effectively perform duties of manufacturing within GeminiBio.

Manufacturing Associate I:

Learns and executes standard manufacturing work safely and compliantly under supervision. Focus is Right-The-First-Time execution, adherence to Standard Work, and identification/escalation of abnormalities.

Manufacturing Associate II:

Executes independently, troubleshoots routine issues, and actively contributes to problem solving and process improvement. Begin improving Standard Work and coaching others.

Manufacturing Associate III:

Acts as a floor-level leader and Subject Matter Expert (SME). Leads problem solving and improvement initiatives, drive proper documentation under cGMP, coaches others, supports readiness/scheduling, and executes actions aligned to strategy deployment. Key Responsibilities (Applies to all levels)

• Abide by all safety requirements and company policies.
• Perform manufacturing operations (e.g., formulation, filling, inspection, cleaning) per assigned training in accordance with cGMP, GDP, SOPs, Wis and batch/manufacturing records
• Document work in real time and maintain accurate and complete records.
• Maintain required cleanroom gowning, aseptic qualifications, and training compliance.
• Support deviation / nonconformance reporting and investigations as assigned; escalate issues promptly per the Tier System.
• Perform cleanroom sanitization and associated activities as trained.
• Operate and maintain production equipment as trained; support equipment readiness and upkeep.
• Collaborate effectively with QA, QC, Engineering, EHS, Procurement, and Development to execute manufacturing objectives.
• Perform shift, overtime, weekend, or holiday work as business needs require.
• Maintain inspection readiness at all times.
• Perform other duties as assigned. A) Manufacturing Associate I
• Level Responsibilities
• Perform routine manufacturing operations under supervision or with a qualified buddy/trainer.
• Follow SOPs, WIs, and batch records to execute tasks Right-The-First-Time (RTFT).
• Document activities per GDP.
• Identify and immediately escalate safety, quality, compliance, or process abnormalities via Tier 1.
• Do not deviate from Standard Work or make process changes without escalation/approval
• Operate standard equipment as trained (e.g., autoclaves, pumps, balances, pH and osmolality meters) and complete basic checks.
• Perform basic material movements/staging per defined processes (labeling, status checks, line clearance support).
• Participate in Tier 1 daily stand-up meetings.
• Maintain 5S standards in assigned areas.
• Demonstrate awareness of visual management boards and key performance metrics. B) Manufacturing Associate II
• Level Responsibilities
• Independently execute routine manufacturing operations in compliance with SOPs, batch records, and GDP.
• Recognize, document, and escalate deviations; support investigations by collecting accurate facts/data.
• Participate in change control activities as assigned (e.g., evidence collection, implementing actions, supporting effectiveness checks).
• Review executed forms (Label request, HI, COP log, etc.) for accuracy/completeness prior to submission.
• Perform and verify standard production activities (e.g., solution prep, buffer prep, filtration, filling/inspection) with minimal supervision.
• Troubleshoot routine process/equipment issues within SOP-defined boundaries and escalate non-routine issues through Tier 1.
• Perform routine equipment set-up, checks, and basic maintenance per SOP; support calibration activities as assigned.
• Train and coach Associate I and Technicians on Standard Work, aseptic behaviors, and GDP expectations (as qualified).
• Draft or revise minor SOP/WI updates under supervision (redlines, clarifications, job aids).
• Complete transfer transactions in the ERP system
• Execute inventory cycle count
• Identify 7wastes in the work area and participate in continuous improvement activities.
• Apply basic Problem-Solving thinking (e.g., 5Whys, JDI) to recurring issues and support countermeasure implementation.
• Track and communicate simple operational metrics (e.g., on-time task completion, recurring issues) to the team. C) Manufacturing Associate III
• Level Responsibilities
• Serve as manufacturing SME to ensure safe, compliant, Right-The-First-Time execution across the shift/area.
• Lead or co-lead deviation/nonconformance investigations (root cause, containment, corrective actions) and drive on-time closure.
• Support CAPA development and closure, including verifying that corrective actions are implemented and sustained.
• Drive documentation quality: author/revise SOPs, WIs, and batch record improvements; ensure changes are implemented and training is effective (in collaboration with QA as required).
• Execute and oversee complex or higher-risk operations (as assigned) and coordinate resources to meet schedule.
• Troubleshoot non-routine issues using structured problem solving; partner with QA, Engineering, QC, and Development/ as needed.
• Support equipment qualification/ validation support activities, and New Product Introductions (NPI) as assigned.
• Communicate constraints, readiness, and operational risks to supervisors/managers to support scheduling and execution.
• Primary trainer/mentor for Associate I/II; and ensure adherence to Standard Work and aseptic behaviors.
• Provide on-the-floor coaching for GDP/cGMP decision making and escalation.
• Have a basic knowledge of ERP transactions (e.g., Cost sheet, Generate WO, Transfer products, etc.) per SOP and GDP requirements.
• Execute assigned ERP transactions accurately and in real time (e.g., inventory movements, work order transactions, material transfers) in accordance with SOPs and GDP requirements.
• Identify and promptly escalate ERP discrepancies or data integrity issues through Tier 1.
• Lead small Kaizen events (e.g., 5S, RCCM) to reduce deviations, cycle time, and waste while maintaining compliance.
• Own and improve Standard Work in the area; ensure sustained adherence across the team.
• Use data/trending to identify chronic losses (rework, recurring deviations, downtime) and develop action plans.
• Lead Tier 1 huddles as assigned and ensure actions/follow-ups are closed through the Tier System. Core Competencies
• Customer Centric o Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
• Effective Teamwork o Keen ability to collaborate with a diverse set of colleagues
• often under pressure
• to accomplish business objectives and deliver customer value. Able to identify
• and correct
• the issues degrading the success of teams.
• Personal Leadership o Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
• Planning and Organizing o Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops
• and implements
• actions to accomplish objectives.
• Effective Communications o Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience. Company Values
• Integrity o Doing the right thing
• the first time. Honoring and keeping commitments.
• Intensity o Working with speed and focus to deliver the highest quality results
• on time.
• Involvement o Embracing unique perspectives and treating others with dignity and respect.
• Innovation o Biased to improve processes and products to better serve customers and improve workflows. Required Skills and Experience, Associate I Manufacturing Associate I
• High school diploma or equivalent experience required; Associate or Bachelor's degree in a science/engineering discipline preferred.
• 0•1+ years in a regulated manufacturing, lab, or technical environment preferred.

• Ability to follow detailed written instructions and document work contemporaneously.
• Basic math and measurement skills; comfort using Microsoft Office (Word/Excel).
• Required work in cleanroom environments and sustain aseptic qualification requirements.
• Demonstrated behaviors: teamwork, attention to detail, learning mindset, willingness to adopt Standard Work. Manufacturing Associate II
• Minimum 1-3+ years relevant experience in a regulated manufacturing/lab/technical environment (Minimum 1 year as Manufacturing Associate I).
• Proficient in standard production tasks and in-process testing methods applicable to the area (e.g., pH, osmolality, endotoxin, integrity testing).
• Demonstrated ability to troubleshoot routine issues and escalate appropriately.
• Demonstrated participation in Continuous Improvement (5S sustainment, problem-solving participation, or implemented improvements).
• Must maintain cleanroom and gowning certifications with a history of minimal excursions (as applicable to the role). Manufacturing Associate III
• Expert proficiency in Associate I and II responsibilities with demonstrated leadership behaviors.
• Typically 3-5+ years experience in regulated manufacturing (or Minimum 2 years as Manufacturing Associate II) with strong aseptic/GMP execution.
• Demonstrated capability leading investigations and driving documentation improvements (SOPs/WIs/Batch Record enhancements).
• Demonstrated mentoring/training capability; and sustain performance standards.
• Working knowledge of Lean/Business System tools (5S, structured problem solving/RCCM, Standard Work, Visual Management, Gemba).
• Comfort using operational metrics and trending to prioritize and drive improvements. Physical Demands / Work Environment (All levels; adjust as needed)
• Ability to lift/move up to 40 lbs overhead (or as required by role).
• Ability to work in cleanroom/aseptic manufacturing environments with PPE and gowning requirements.
• Standing, walking, bending, and repetitive motions as required by manufacturing tasks.

Advancement to the next Manufacturing Associate level is based on demonstrated sustained performance, mastery of current-level responsibilities, quality and compliance execution, training completion, and consistent demonstration of company values and leadership behaviors.

Job Type:

Full-time Pay:

$24.00

• $29.

00 per hour Expected hours: 40 per week

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

cleanroom or laboratory: 2 years (Required)

Location:

West Sacramento, CA 95605 (Required) Ability to

Commute:

West Sacramento, CA 95605 (Required)

Work Location:

In person