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Aldevron

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Opportunities at Aldevron

Fargo, North Dakota
  • Quality Control Scientist II - GMP Services

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    Essential Job Functions/Duties

    • Act as primary analyst for GMP projects and completion of appropriate documentation
      • Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
      • Assist in validation of methods, as needed
      • Initiate nonconformance reports for failing materials, Out-of-Spec investigations, Lab Investigations, Root Cause and CAPA related activities
      • Create, revise and update standard operating procedures (SOP) as requested
      • Perform data entry and peer review of quality documents for accuracy in accordance with laboratory procedures, standards and GMP requirements
      • Perform advanced assays requiring precise analytical skills
      • Responsible for the following list of tasks, not intended to be all-inclusive, to be completed and properly documented to ensure customer satisfaction.
      • Preparation of buffers along with pH adjustment
        ⁃ Sampling and analyzing samples of Aldevron’s in-house water system
        ⁃ Generation of Certificate of Analysis
        ⁃ Handling of product, including transfer of material for shipments of in-process samples and outsourced testing


    Minimum Work Experience/Educational Requirements
    • Bachelors degree in Science related field, Microbiology preferred
      • 3 years experience working in a laboratory environment preferred

    Essential Functions/Skills
    • Have good depth perception and steady hands for pipetting
      • Operate precision measuring tools and equipment
      • Have good manual dexterity
      • Work as a team member
      • Ability to follow written procedures and verbal directions

    Reports To
    Director of Quality and Regulatory, however will receive daily work assignments from QC Project Coordinator
    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Quality Control Scientist III - GMP Services

    Open or Close
    Essential Job Functions/Duties

    • Research and assess process/technology improvements
    • Lead or support transfer of methodology from R&D
    • Develop new analytical methods and/or techniques
    • Lead validation of methods
    • Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
    • Create, revise and update standard operating procedures (SOP)
    • Perform data entry and peer review of quality documents for accuracy in accordance with laboratory procedures, standards and GMP requirements
    • Lead analytical investigations
    • Perform advanced assays requiring precise analytical skills


    Minimum Work Experience/Educational Requirements
    • Bachelors degree in Science related field, Microbiology preferred
    • 3 years experience working in a laboratory environment preferred

    Essential Functions/Skills
    • Have good depth perception and steady hands for pipetting
    • Operate precision measuring tools and equipment
    • Have good manual dexterity
    • Work as a team member
    • Ability to follow written procedures and verbal directions

    Reports To
    Director of Quality and Regulatory, however will receive daily work assignments from QC Project Coordinator

    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Quality Metrology Engineer Technician

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    The Quality Metrology Engineer Technician (QMET) is responsible for the following activities:
    • Performs, as assigned, a variety of installation, maintenance, troubleshooting and repair duties on the facility and equipment.
    • Perform routine calibration/scheduled maintenance to ensure compliance of the equipment/system for its intended use is maintained and that manufacturing operational requirements are met.
    • Replace/repair/clean equipment and facility utilities as needed.
    • Complete facility documentation including calibration data sheets.

    Knowledge/Experience/Skills:
    • Possess strong ability to troubleshoot and repair equipment.
    • Good organizational, communication and time management skills.
    • Strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions.
    • Must be a self-motivator that is able to work both independently and as part of a team.
    • Must be willing to be on-call after hours.
    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Client Relations Manager – GMP- Source

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    Job purpose:
    Build strategic and long-term relationship with clients, particularly those in the fields of gene therapy and molecular diagnostics, by understanding their technical requirements, clinical and commercial goals and offering an appropriate custom manufacturing solution.


    Duties and Responsibilities:
    • Develop relationships with existing clients and establish new relationships with relevant prospects and leads relevant to clinical/diagnostic grade plasmid DNA
    • Grow clinical/diagnostic grade pDNA business with the ability to quickly identify and share opportunities for Research-grade Plasmid, Protein & Antibody service platforms
    • Travel to clients and relevant conferences to present Aldevron’s service portfolio to scientific personnel and procurement Directors / Managers and Executive staff
    • Meet with clients in person and over the phone to understand requirements, communicate project information and support business development efforts
    • Work closely with Aldevron marketing colleagues to develop and launch marketing initiatives to create awareness for existing and new products and services
    • Work closely with Aldevron’s internal teams to continuing refining the business development process, and input / track information in a Client Relationship Management software system
    • Expand business and contacts at target key pharma, biotech and diagnostic clients
    • Write detailed business proposals for distribution to client with support from Manufacturing/Quality team
    • Interface routinely with Quality/Regulatory, scientific and project management personnel at Aldevron
    • Communicate client feedback to management regarding new service opportunities with suggestions to improve Aldevron’s service
    • Demonstrate high ethical standards and trustworthiness.
    • Ability to manage multiple projects in a fast paced team orientated environment.
    • Position requires approximately 10-25% travel and reports to GMP-Source Client Relations Manager.
    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Quality Assurance Specialist

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    Basic Function: The Quality Assurance Specialist (QAS) is responsible for supporting the quality system processes including Internal Audits, CAPAs, Document Control and Supplier Quality by the following activities:
    • Responsible for maintaining quality assurance standards, processes and controls. Develops and implements methods for inspection, testing, sampling, and training.
    • Support quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
    • Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual.
    • Expected to be familiar with all of Aldevron's products and services and all associated systems with a good understanding of molecular biology, microbiology, biochemistry and cell biology.
    • Identifies compliance risks at Aldevron through auditing process

    Support of the CAPA system by:
    • Ensuring all events are adequately investigated
    • Appropriate CAPA actions are put into place
    • Records are closed within a timely manner

    Support of Aldevron’s internal audit program are performed in accordance with procedures and other applicable external requirements and appropriately and adequately identifying and prioritizing internal risks through the internal audit process and ensure deficiencies are addressed which includes:
    • Performance of internal audits as scheduled, maintaining documentation as required
    • Performance of in-process audits as scheduled, maintaining documentation as required

    Support of the qualification and monitoring of Aldevron’s suppliers/vendors which includes:
    • Performance of supplier quality audits as scheduled, maintaining documentation as required

    Support of maintaining the Document Control process by ensuring all quality records within the Document Control system are maintained effectively, which includes:
    • Performance of document updates as scheduled, maintaining documentation as required
    • Assignment of training to appropriate individuals
    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Material Handler

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    Job Summary
    Receives and issues inventory to/from the manufacturing operation. Properly identifies material and is accountable for its accuracy in the stock locations. Inventories material and equipment from Receiving and from Production.

    Job Functions
    • Responsible for maintaining quality standards, processes and controls. Helps develop methods for inspection, testing, material control, and shipping.
    • Follow established process for control of final material. Including material management for inventory, storage location.
    • Pulling material from stock to build kits.
    • Load material into company van or truck.
    • Deliver material to people or companies via company van or truck, with valid drivers license and complying with vehicle requirements.
    • Filling and accounting for material requisitions submitted by Manufacturing
    • Maximizing inventory control processes.
    • Receiving and placing material and equipment into stock from Receiving and Manufacturing.
    • Responsible for the receipt of materials into the Raw Materials Management database.
    • Tracking and monitoring inventory levels
    • Making sure incoming material is label appropriately.
    • Additional duties and responsibilities as required or assigned.

    Position Scope and Magnitude:
    • This position will have interaction with the entire organization through the process of supporting incoming materials and equipment of Aldevron product. The criticality of this function is responsibility of maintaining accurate inventory control of raw material and equipment.
    • This position will work directly with Material Manager to meet client and Aldevron expectations.

    Required Qualifications:
    Valid Driver’s Licence

    Education:
    High School diploma
    To Apply
    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • Technical Writer

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    The role of the Technical Writer will be to work as a resource in writing, reviewing, implementing, and maintaining technical documents for our GMP Production area. Documents include, but are not limited to, standard operating procedures, production records, Master Batch Records and process development reports. Key responsibilities and duties include the ability to organize and write required documents per established organizational guidelines.

    Essential job functions and duties include:

    • Create, update, review, and sign off on new and/or revised Standard Operating Procedures, Production Records, Master Batch Records, and Forms;
    • Work closely with Manufacturing and Quality Assurance to ensure all processes conform to quality requirements;
    • Manage timelines and direct others as needed in documentation workflows;
    • Discuss project status directly with key clients;
    • Consult with the technical team and other subject matter experts to ensure common understanding of publications and related materials to be produced;
    • Remain current on new developments in technical writing, editing and publishing;
    • Report, review and update technical metrics as requested or needed;
    • Respond to Director of Bio-Manufacturing as assigned with accurate and timely work to facilitate the needs of the organization.

    Qualifications and skills:
    • Excellent English, Communication and Technical Writing skills;
    • 2+ years of experience in Technical Writing or Communications with demonstrated growth in your responsibilities over time;
    • Bachelor’s Degree in English or Communications with an editing or writing emphasis;
    • Prior work in a GMP manufacturing environment is preferred;
    • A demonstrated history of progressive accountability;
    • Fluency in Microsoft Office and Outlook;
    • Witness new processes and be able to develop written processes that meet all quality requirements;
    • Engage with all levels and within the organization, and at the same time, the willingness to roll up your sleeves in order to make things happen;
    • Deliver high quality work for the GMP;
    • Work in a flexible manner; The ability to self-start and self-manage;
    • Have a meticulous attention to detail.

    This position will be located in of our Fargo office and will report to the Director of Bio-Manufacturing. This function will work closely with several levels of the organization to provide technical writing requirements that will be used throughout the organization.

    Aldevron offers a competitive compensation and benefit package. This position is located in our Fargo, N.D. corporate office.

    To Apply

    Send a cover letter, resume, and three references to: recruiting@aldevron.com
  • GMP Production Scientist

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    The Production Scientist will work daily within Aldevron’s labs performing tasks associated with Aldevron’s GMP and GMP-Source (GMP-S) services. The Production Scientist is expected to become familiar with all of Aldevron’s products and to be able to perform most tasks associated with the purification of plasmid DNA.

    Essential job functions and duties include:
    • Segregation, line clearance, and cleaning of GMP/GMP-S production areas.
    • Assembly and segregation of all raw material and equipment resources for GMP/GMP-S production runs.
    • Execution of GMP/GMP-S projects and special considerations associated.
    • Completion of all documentation associated with GMP/GMP-S projects.
    • Equipment calibration and preventative maintenance.
    • Assisting in writing and completing Manufacturing Summary Reports after GMP/GMP-S project completion, Standard Operating Procedures, and Master Batch Records as needed.
    • Assist with the maintenance of personal training record (production training, safety training, etc)
    • Initiation and completion of deviation paperwork, and other required documents.

    Knowledge/Education Requirements:
    • High School Diploma
    • BS Degree in Biology, Chemistry, or Molecular Biology preferred.

    Functions and skills:
    • Speak and write fluently in English.
    • Apply basic math (arithmetic, ratios, proportions and conversions).
    • Have good depth perception and steady hands as would be needed for pipetting into small vials.
    • Have good manual dexterity as needed for shaking, moving, agitating, etc. glass vials and bottles.
    • Lifting and moving boxes of 35 lbs. or less.
    • Work as a team member.
    • Following written procedures, and written and verbal directions.
    • Keep records and maintain files.
    • Use computer and computer keyboard.
    • Good communication skills as needed for reporting, documentation, and scheduling.
    • Adhere to safety, health, and sanitation procedures.
    • Ability to stand for long portions of time and manipulate large equipment.
    • Good organizational skills.
    • Ability to self-report mistakes or concerns to their manager.
    • Follow-through on methodology, understanding that bacteria are living organisms that do not adhere to a schedule.

    This position will be located in of our Fargo office.

    Aldevron offers a competitive compensation and benefit package. This position is located in our Fargo, N.D. corporate office.

    To Apply

    Send a cover letter, resume, and three references to: recruiting@aldevron.com
Madison, Wisconsin
There are currently no positions available at Aldevron's Madison location. If you would like to have your information on file for future opportunities, please send a cover letter and resume/CV to recruiting@aldevron.com
Freiburg, Germany
There are currently no positions available at Aldevron's Freiburg location. If you would like to have your information on file for future opportunities, please send a cover letter and resume/CV to recruiting@aldevron.com