Technical Operations Manager, mRNA at ALDEVRON, LLC in Fargo, North Dakota

Job Description:

The Technical Operations Manager, mRNA is is responsible for the oversight of all activities completed in the mRNA Technical Operations group, including scientific reviews, planning and scheduling, and project management.  

Responsibilities

• Direct oversight of all mRNA Associate Scientists, Technical Operations


• Generate and update detailed project tasks and timelines for all internal and client-facing activities


• Assist with or conduct effective performance reviews on a scheduled basis


• Review and approve new documents created by mRNA Technical Operations department, including manufacturing batch records, SOP’s, and tech transfer documents


• Review scientific protocols and summary reports generated within the department


• Continuously engage personnel on continuous improvements within a culture valuing efficiency


• Support continuous improvement projects addressing process efficiency, product costs, and performance


• Participate in technical calls and routine project updates with Aldevron clients
  
  
  
  • Provide timeline and milestone updates on tech transfers
  
  
  • Create summary slides and present technical information, including process development/optimization data, investigation findings and remediations, and manufacturing updates
  
  
  
  


• Ensure all laboratory spaces are kept in a clean, safe, and orderly status at all times


• Generate, review, and approve Raw Material Authorization documentation for new incoming materials


• Coordinate department personnel onboarding process
  
  
  
  • Lead interview process
  
  
  • Prepare and update written training plans for all department employees
  
  
  • Support organizational goals and engage employees in working toward successful achievements
  
  
  
  


• Assist GMP and GMP-S manufacturing teams with laboratory investigations and closure of CAPA’s


• Ensure all CAPA tasks are closed within the defined timelines


• Lead project planning and support department personnel with any questions and issues that arise during daily activities


• Assist with supporting strategic plans for process and facility improvements in order to increase efficiency


• Work collaboratively with cross functional departments

Required Skills

• Excellent verbal and written communication skills


• Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership


• Ability to balance changing priorities and delegating tasks


• Strategic agility, strong critical and logical thinking with ability to analyze problems


• Ability to mentor and motivate a team to deliver results and meet deadlines


• Knowledge of GMP’s and regulatory requirements for biologics manufacturing


• Communicate effectively with cross-functional teams, including Technical Operations, site leadership, Manufacturing, Process Development, and Quality


• Ability to effectively organize and work in a fast-paced, multitasking, deadline-driven work environment under pressure


• Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally


• Ability to troubleshoot issues


• Communicate effectively with cross-functional teams, including Technical Operations, site leadership, Manufacturing, Process Development, and Quality


• Ability to effectively organize and work in a fast-paced, multitasking, deadline-driven work environment under pressure


• Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally


• Ability to troubleshoot issues

Must-Haves

• Minimum of a B.S. in a scientific field is required


• Minimum 5 years experience in GMP biologics manufacturing


• Experience with bioprocessing of mRNA


• Experience in process development and biomanufacturing


• Ability to travel up to 10%

Working Conditions/Physical Requirements 

This position operates in a professional office environment as well as a manufacturing setting, and may come in contact with various solutions and chemicals. This position also routinely works with large pieces of equipment.  

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

See job description