Talent.com
No longer accepting applications
Downstream Manufacturing Associate

Downstream Manufacturing Associate

AstrixMorrisville, NC, US
12 days ago
Job type
  • Full-time
Job description

Job Description

Position Summary :

The Manufacturing Process Technician is responsible for executing GMP manufacturing processes including upstream and downstream operations, material handling, and batch documentation. This role ensures consistent production of high-quality clinical materials and supports the successful transfer of new processes into manufacturing.

Morrisville, NC

Contract (potential for conversion)

Multi-shift availability (1st and 2nd shifts)

Pay : $35–$42 / hour

Looking for experience with AKTA

Key Responsibilities :

  • Perform manufacturing operations from cell expansion through purification following MBRs and SOPs
  • Prepare buffers and support solutions; pack, qualify, and clean chromatography columns
  • Operate and maintain analytical and manufacturing equipment in cleanroom environments
  • Edit and maintain SOPs, logbooks, and batch documentation in accordance with GDP
  • Coordinate with supply chain on raw material delivery, cleaning, and stocking
  • Support waste decontamination and removal following EHS standards
  • Enter production data into databases and assist with batch closeout activities
  • Ensure compliance with cGMP, GDP, CFRs, and internal quality policies
  • Collaborate with cross-functional teams on tech transfers and troubleshooting production issues

Qualifications : Required :

  • A.S. degree, Biomanufacturing certification, or equivalent experience
  • Familiarity with FDA regulations, cGMP, and GDP documentation standards
  • Effective communication skills and ability to work collaboratively in a team
  • Flexibility to work varied shifts including nights and weekends
  • Ability to lift 25 lbs routinely and up to 50 lbs occasionally
  • Preferred :

  • B.S. in Biochemistry, Bioengineering, Chemical Engineering, or related field
  • 2+ years of GMP biologics manufacturing experience (e.g., cell culture, purification, aseptic fill / finish)
  • Experience with single-use systems and GMP batch record management
  • This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

    Create a job alert for this search

    Manufacturing Associate • Morrisville, NC, US

    Related jobs
    • Promoted
    Associate Director, Manufacturing Science & Technology - Visual Inspection, Device Assembly and Packaging

    Associate Director, Manufacturing Science & Technology - Visual Inspection, Device Assembly and Packaging

    Novartis Group CompaniesDurham, NC, United States
    Full-time
    The Associate Director, Manufacturing Science and Technology is responsible for leading the Manufacturing Science and Technology organization at a manufacturing site to ensure consistent and visual...Show moreLast updated: 13 days ago
    • Promoted
    Associate Director, Pricing & Contracts Operations, AIR

    Associate Director, Pricing & Contracts Operations, AIR

    ChiesiCary, NC, United States
    Full-time
    Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 7,000 employees across the group are united...Show moreLast updated: 7 days ago
    Manufacturing Associate (Contractor)

    Manufacturing Associate (Contractor)

    Sunrise SystemsMorrisville, North Carolina, United States
    Full-time
    Quick Apply
    Manufacturing Associate (Contractor).Duration : 07 Months On W2 Contract.Participate in process validation activities and ongoing manufacturing for client. Develop a suitable level understanding of C...Show moreLast updated: 30+ days ago
    • Promoted
    Manufacturing Associate 1+ years experienced - Biologics (contract)

    Manufacturing Associate 1+ years experienced - Biologics (contract)

    Randstad EnterpriseDurham, NC, United States
    Full-time
    In this Biomanufacturing Associate position, you will have an opportunity to work in a well-respected Biotechnology company AND have the support you need with a career coach guiding you towards suc...Show moreLast updated: 1 day ago
    • Promoted
    Manager, CQV

    Manager, CQV

    FUJIFILMHolly Springs, NC, US
    Full-time
    The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility.This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill)...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Business Finance Partner - API

    Associate Business Finance Partner - API

    Novo NordiskClayton, NC, United States
    Full-time
    At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide.For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our e...Show moreLast updated: 15 days ago
    Utility Operator / Facility Associate

    Utility Operator / Facility Associate

    Software Galaxy Systems, LLCDurham, North Carolina, United States
    Full-time
    Quick Apply
    Duration : 6 Months+ (Possible extension).Pay rate : up to $30 / hourly on W2.The primary role of a Utility Operator at a Biogen is to ensure the safe, reliable, and continuous operation of all critica...Show moreLast updated: 30+ days ago
    Floating Associate

    Floating Associate

    Huff ConsultingButner, North Carolina, United States
    Full-time
    FAST FOOD WORKERS, WE WANT YOU • •.Floating Associate is responsible for assisting Production and Packaging Associates in operations, setups, adjustments on equipment, and general labor on the produc...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Manufacturing Science & Technology - Drug Product

    Associate Director, Manufacturing Science & Technology - Drug Product

    Novartis Group CompaniesDurham, NC, United States
    Full-time
    The Associate Director, Manufacturing Science and Technology is responsible for leading the Manufacturing Science and Technology organization at a manufacturing site to ensure consistent and reliab...Show moreLast updated: 14 days ago
    • Promoted
    Plasma Material Handling Associate Operator 2nd shift

    Plasma Material Handling Associate Operator 2nd shift

    StaffingDunn, NC, US
    Full-time
    Plasma Material Handling Associate Operator.This position is the point of contact for plasma operations at the Plasma Logistics Center where the incumbent receives raw materials (plasma) from donor...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Clean Validation

    Associate Director, Clean Validation

    FUJIFILMHolly Springs, NC, US
    Full-time
    Associate Director, Cleaning Validation.The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale biologics manufact...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director QA for Materials, Supply Chain and QC

    Associate Director QA for Materials, Supply Chain and QC

    FUJIFILMHolly Springs, NC, US
    Full-time
    The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehous...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance Associate

    Quality Assurance Associate

    Meet Life SciencesRaleigh, NC, United States
    Full-time
    GMP, regulatory, and company quality standards.This role supports batch record review, deviation management, and quality oversight of production operations to maintain product integrity and complia...Show moreLast updated: 8 days ago
    • Promoted
    Manager, Manufacturing Support

    Manager, Manufacturing Support

    Novartis Group CompaniesDurham, NC, United States
    Full-time
    The Manufacturing Support Manager develops, organizes, and executes the implementation of the Critical Environment Cleaning Program across the business. This position will also be responsible for th...Show moreLast updated: 14 days ago
    • Promoted
    Dedicated CDL-A Truck Driver - Home Weekly - Earn Up to $83,000 / Year

    Dedicated CDL-A Truck Driver - Home Weekly - Earn Up to $83,000 / Year

    C.R. EnglandNewton Grove, NC, US
    Full-time
    England is Now Hiring Experienced CDL-A Company Drivers!.Home Weekly - Drivers Average $61,000 Annually •.Valid CDL-A and 3+ months of current experience required. This lane is not suitable for stude...Show moreLast updated: 3 days ago
    Print Production Associate

    Print Production Associate

    Duncan-Parnell IncRaleigh, North Carolina, United States, 27603
    Full-time
    Duncan-Parnell is one of the Southeast’s leading distributors of technology products and services for the construction, engineering, survey, and design industries. With a rich history of over 75 yea...Show moreLast updated: 30+ days ago
    • Promoted
    Manager Manufacturing Single Use Systems - Holly Springs, NC

    Manager Manufacturing Single Use Systems - Holly Springs, NC

    VetJobsHolly Springs, NC, US
    Full-time
    Manager Manufacturing Single Use Systems - Holly Springs, NC.In this vital role, you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufa...Show moreLast updated: 28 days ago
    • Promoted
    • New!
    Downstream Process Engineer

    Downstream Process Engineer

    Technical SourceHolly Springs, NC, United States
    Full-time
    Downstream Process Engineer – 2nd Shift (Biologics Manufacturing) | Holly Springs, NC.Technical Source is partnering with a global biopharmaceutical leader to support a major facility expansion in ...Show moreLast updated: 2 hours ago