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Supervisor, Manufacturing Support

Supervisor, Manufacturing Support

Requisition Number 
17-951
Category 
Manufacturing
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Supervisor, Manufacturing Support is a managerial position responsible for planning and executing manufacturing activities in the Support area of a cGMP manufacturing area which include: weigh and dispense, buffer prep, media prep, facility cleaning, equipment cleaning, and raw material ordering. This individual will forecast monthly activities, plan daily activities and ensure staff are focused on these activities. The individual will drive actions to ensure adherence to overall production schedule and lot release schedule while maintaining a high level of quality and compliance. This is a hands-on role where the supervisor will frequently be working directly with the team to ensure that work is done accurately and on-time. 

 

Responsibilities and Job Duties

  • Perform duties in accordance with site SOPs, EH&S standards and guidelines, and relevant legal requirements and ensure that their team does the same.
  • Ensure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
  • Perform and supervise others doing weigh and dispense, buffer prep, media prep, facility cleaning, equipment cleaning, and raw material ordering.
  • Ensure successful implementation of new products and processes into the facility by creating new solution records, SOPs, and change controls, procuring new equipment, and completing area changeover activities.
  • Open and/or evaluate deviations for potential impact.
  • Effectively troubleshoot production equipment and process problems of varying scope.
  • Be accountable for Manufacturing Associate development and/or performance management through activities such as assignments and associated technical training programs.
  • Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
  • Work on problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors.
  • Participate in and implement continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations.       
  • Schedule and coordinate activities with other departments such as Quality Assurance, Quality Control, Facilities, Materials Management, and Validation.

Qualifications

Education & Experience

  • Associates/Bachelors degree in scientific discipline and a minimum of 3 years of experience working in a cGMP environment OR High School Diploma or successful completion of GED and a minimum of 8 years of experience working in a cGMP environment
  • Minimum of 1 year of experience preparing media and/or buffers
  • Minimum of 1 year of experience cleaning or supervising the cleaning of pharmaceutical clean rooms

Knowledge, Skills and Abilities

  • Excellent leadership skills
  • Ability to influence others without direct authority
  • Excellent organizational skills and attention to detail required
  • Results driven with demonstrated successful outcomes
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
  • Ability to handle multiple priorities in a fast-paced environment
  • Excellent written and verbal communications skills
  • Basic knowledge of chemistry
  • High degree of comfort with basic arithmetic
  • Proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
  • Ability to lift at least 30 lbs

Preferred Qualifications

  • Familiarity with Six Sigma
  • Ability to lead and document formal risk assessments
  • Experience writing Regulatory documents (IND, BLA)

Supervisory Responsibilities

  • Manufacturing Associates
  • Manufacturing Technicians

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.