GMP-Source Production Manager

Organization
Aldevron
Job Location
Fargo, ND 58104
Benefits

Health, Vision, Dental, Life, 401k w/match, FSA/HSA, PTO

Job Description

Position Summary:

The GMP-Source Production Manager will work daily within Aldevron's labs performing tasks associated with Aldevron's GMP services. The GMP/GMP-Source Production Coordinator 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 Duties and Responsibilities:

  • Plan and schedule facility and equipment maintenance tasks with Metrology as appropriate with scheduled resources.
  • Coordination with Research Grade, Metrology, Quality Control, Quality Assurance and Project Management as needed on the scheduled production.
    • Assist with coordination of manufacturing samples going go Quality Control for testing, material going to Research Grade for qualification, warehouse requisitions priorities as well as material receiving priorities and tracking of warehouse stored materials.
  • Assist with updating, and writing SOPs and forms as needed.
  • Plan and prepare GMP-Source shipping schedule. Work with Project Management and shipping personnel on planning and scheduling.
  • Assist with Raw Material updates and tracking of the status and approval of Raw Material Authorization paperwork.
  • Review dashboard, and ensure staff are updating appropriately. Communicate with Project Management on status updates. Ensure production lot peer reviews and quality audits are completed within designated timelines.
  • Work with Document Coordinator(s) as needed to review archival records that have reached the retention time to determine if they should be destroyed or retained for another life cycle.
  • Schedule classroom training events for new staff (Good Documentation Practices, AssuRx, etc.)
  • Assist with classroom training of Aseptic Technique Modules.
  • Coordinating the documentation of non-conforming materials, ensuring Material Review Board meetings are scheduled. Track the Material Review Board process.
  • Ensure all quality documents within the Document Control system are maintained effectively, which includes to ensure periodic review schedule of documents is met. As well as to ensure procedures are maintained in a manner clearly defining the process steps and in enough detail to provide the necessary guidance to any individual following the procedure.
  • Ensuring document periodic review tasks are completed on time.
  • Directly supervise all GMP-Source staff.
  • Conduct performance reviews on a scheduled basis.
  • Assist in the implementation of new processes and procedures. This includes updating and writing SOPs and forms as well as oversight of training of the laboratory staff.
  • Execution of Corrective Actions and deviations.
  • Prepare and work on Performance Improvement Plans with staff as needed.
  • Review and approval of staff vacation requests.
  • Oversight and support of the CAPA system. Ensure all events are adequately investigated and that appropriate CAPA actions are put into place. Ensure records are closed in a timely manner, within the assigned due date.
  • Managing the GMP-Source production scheduling.
  • Review and maintenance of the departmental training program.
  • Responsible for following Aldevron SOPs and adhering to regulatory expectations.
  • Responsible for identification of needs for internal and external training beyond standard training process.
  • Review and approval of staff production kick off plans. Support staff with project planning and any questions that arise during production or other daily activities.
  • Update department staff training plans.
  • Ensure staff are qualified, independent, trained and assigned to activities supporting Manufacturing as required.
  • Assist and participate in process and product development/optimization, scale-up and tech transfer.
  • Review and approval of staff training records.
  • Track production lots, and date of manufacture of production events.
  • Review and approve staff training plans.
  • Providing support during external inspections performed of Aldevron by regulatory agencies/clients and leading Corrective Actions from inspection findings.
  • Assist with maximizing success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations and procedural error. Assist with supporting strategic plans for process and facility improvements in order to increase efficiency.
  • Review edits and updates of department SOPs and forms.
  • Provide oversight to ensure appropriate actions are taken to remediate gaps identified in both internal audits and client inspections or areas of improvement. This includes working collaboratively with cross functional departments. As well as leading or being an active member on project teams to ensure processes are performed in accordance with Aldevron procedures and all other business and regulatory requirements are met.
  • Review and compile report on Quality & Business Metrics Tracking
  • All employees are responsible for the general upkeep of work and shared spaces.
  • Other duties as assigned.
Requirements

Qualifications:

Experience:

  • 7 Years or More Related Experience

Education:

  • BS/M Degree in Biology, Chemistry, or Molecular Biology

Skills and Knowledge:

  • Excellent verbal and written communication skills
  • Strong knowledge of computers, Microsoft Office, and Smartsheet
  • Above average organizational skills

Abilities:

  • Ability to apply basic math (arithmetic, ratios, proportions and conversions)
  • Ability to work effectively as part of a team
  • Ability to follow written procedures, and written and verbal directions
  • Ability to keep records and maintain files
  • Ability to adhere to health, safety and sanitation procedures
  • Ability to self-report mistakes or concerns to reporting manager

Working Conditions:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.

This position may also work in a segregated lab setting and may come in contact with various solutions and chemicals, and will be responsible for activities related to biological processes such as bacterial growth.  This position uses standard laboratory equipment such as pipettes, centrifuges, glass ware, shake flasks, fermenters, fume hoods, and computers.  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities.  This position may stand or remain sedentary for long periods of time.  This position routinely works with large pieces of equipment.

Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.

EEO

How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/500178-149639   

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