Jobs
>
Durham

    Manufacturing Associate I/II - Durham, United States - KBI Biopharma

    KBI Biopharma
    KBI Biopharma Durham, United States

    3 weeks ago

    Default job background
    Full time
    Description

    Position Summary

    This position operates on a 2-2-3 schedule with the hours of 7:00 am - 7:30 pm. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted "Right First Time" (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

    The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest). The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance.

    The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability.

    Position Responsibilities

  • Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality, company policies, and current regulations
  • Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures
  • Document each task involving manufacturing records and logbooks following GDP at the time of execution
  • Utilize and perform maintenance on equipment per applicable SOP
  • Ensure all materials are issued and accounted for during the execution of a record
  • Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities
  • Participate and be accountable for workplace organization

    • Position Requirements

  • Manufacturing Associate I- Bachelor's degree in a related scientific or engineering discipline and 0-2 years' experience in related cGMP manufacturing operations; or high school diploma and 3-5 years' experience, or equivalent
  • Manufacturing Associate II- Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations; or high school diploma and 4-6 years' experience, or equivalent
  • Basic knowledge of upstream processing- cell culture or fermentation
  • Experience in single-use platform technology is preferred

    • Salary Range: $24-$31.25/hour

    Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

  • KBI Biopharma

    Manufacturing Associate I/II

    3 weeks ago

    KBI Biopharma Durham, United States Full time

    Position Summary · This position is on a 2-2-3 shift, 7a-7p. The Manufacturing Associate I/II – Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. · The Manufacturing Associate I/II – Dow ...

  • KBI Biopharma

    Senior Manufacturing Associate I/II

    3 weeks ago

    KBI Biopharma Durham, United States Full time

    Position Summary · The Senior Manufacturing Associate I/II is responsible for performing upstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Senior Manufacturing Associate must follow written, approved procedures and forms to ...

  • KBI BioPharma

    Manufacturing Support Associate I/II

    1 week ago

    KBI BioPharma Durham, United States

    Job Description · Position Summary · This position is on 2-2-3 shifts, 7p-7a. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. · The Manufacturing Associate I/II - Support must follow ...

  • KBI Biopharma

    Manufacturing Support Associate I/II- Days

    3 weeks ago

    KBI Biopharma Durham, United States

    Position Summary · This position is on 2-2-3 shifts, 7a-7p. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. · The Manufacturing Associate I/II – Support must follow the instructions d ...

  • Duke Health

    Pharmacy Technician I/II

    3 weeks ago

    Duke Health Durham, United States Regular

    Pharmacy Technician I/II - Ambulatory/Retail · Work Arrangement: Requisition Number: Regular or Temporary: Regular Location: Durham, NC, US, 27710 · Personnel Area: DUKE REGIONAL HOSPITAL Date: May 18, 2024 At Duke Health, we're driven by a commitment to compassionate care tha ...

  • BioAgilytix

    Scientist I/II

    6 days ago

    BioAgilytix Durham, United States

    At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly ...

  • The Shade Store

    Production Associate I

    2 days ago

    The Shade Store South Hill, United States

    At The Shade Store · We have handcrafted the finest Shades, Blinds and Drapery for 75 years. We believe designing beautiful custom window treatments should be an effortless experience, so we offer outstanding services to help our customers every step of the way, from inspiration ...

  • Corning

    Manufacturing Associate I

    3 weeks ago

    Corning Durham, United States

    Requisition Number: 63444 · Corning is vital to progress – in the industries we help shape and in the world we share. · We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful inve ...

  • Duke University

    Clinical Technician I/II

    4 days ago

    Duke University Durham, United States

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke Primary Care · Pursue your p ...

  • PSG Global Solutions Careers

    Quality Associate I

    2 weeks ago

    PSG Global Solutions Careers Durham, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Quality Associate I (Q and V), working in Pharmaceuticals and Medical Products industry in 5000 Davis Drive, Durham, North Carolina, 2 ...

  • ZINNIA

    Sales Associate II

    3 weeks ago

    ZINNIA Durham, United States

    WHO WE ARE: · Zinnia is simplifying how people buy, sell, and administer insurance products. Combining intuitive enterprise technology solutions and data insights, the Policygenius marketplace, and market-leading products including SmartOffice, AnnuityNet, LifeSpeed, WinFlex, T ...

  • Asklepios Biopharmaceutical

    Research Associate I

    3 weeks ago

    Asklepios Biopharmaceutical Durham, United States

    Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...

  • KBI Biopharma

    Associate Scientist/Scientist I

    3 weeks ago

    KBI Biopharma Durham, United States Full time

    Position Summary: · Perform contract testing services, including in-process and release testing, method transfer activities, and qualification/validation activities for monoclonal antibodies, recombinant proteins, and peptides · Position Responsibilities: · Performs testing on ...

  • Penn Foster Inc

    QA Manufacturing Specialist II/I

    3 weeks ago

    Penn Foster Inc Durham, United States

    Position Summary · We are seeking a highly motivated QA Manufacturing Specialist I/II at our brand-new state of the art commercial manufacturing facility in Patriot Park, Durham, NC. · You will be one of the first members of the QA manufacturing team and have the unique opportu ...

  • FUJIFILM

    QC Lead Associate I

    1 day ago

    FUJIFILM Research Triangle Park, United States

    The QC Lead Associate I position is a position that supports a variety of microbiological disciplines within the Quality Control laboratory. The individual performs laboratory work as assigned to meet production schedules and project milestones and will work with minimal supervis ...

  • FUJIFILM Corporation

    QC Lead Associate I

    2 weeks ago

    FUJIFILM Corporation Durham, United States

    Overview: · The QC Lead Associate I position is a position that supports a variety of microbiological disciplines within the Quality Control laboratory. The individual performs laboratory work as assigned to meet production schedules and project milestones and will work with min ...

  • HUMACYTE GLOBAL INC

    Warehouse Logistics Associate II

    3 weeks ago

    HUMACYTE GLOBAL INC Durham, United States

    Job Description · Job DescriptionWarehouse Logistics Associate II Position Profile · Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving ...

  • HUMACYTE GLOBAL INC

    3D Bioprocessing Associate II

    3 weeks ago

    HUMACYTE GLOBAL INC Durham, United States

    Job Description · Job DescriptionPosition Overview: · The Bioprocessing Associate 2 participates in the hands-on production of Humacyte's regenerative vessels. · Major Accountabilities: · Performs basic/moderate scope processes and serves as a hands-on resource in Manufacturing H ...

  • Biogen

    Associate II, Quality Assurance Biologics

    1 week ago

    Biogen Durham, United States

    The Associate II, Quality Assurance Biologics will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities i Quality Assurance, Assurance, ...

  • Biogen

    Associate II, Quality Assurance Biologics

    1 week ago

    Biogen Durham, United States

    Job Description · The Associate II, Quality Assurance Biologics will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities include revie ...