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Manager/Senior Manager, Protein Purification Manufacturing

Manager/Senior Manager, Protein Purification Manufacturing

ID 
2017-1086
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 Manager/Senior Manager, Protein Purification Manufacturing is responsible for planning and driving the execution of manufacturing activities in the Protein Purification area of a cGMP manufacturing area. This position will forecast monthly and weekly activities, plan daily activities and ensure staff are focused on these activities. He/She will motivate the team and drive actions to ensure adherence to overall production schedule and lot release schedule while maintaining a high level of quality and compliance. This position may also require some hands on support with the manufacturing processes.

 

Responsibilities and Job Duties

  • Manage a team of Manufacturing Associates in Protein Purification area who conduct purification operations including filtration, chromatography, titrations, and column packing and order and account for consumption of raw materials and components. Identify and clearly communicate expectations, schedule and monitor work progress, provide guidance and direction, evaluate results, and deliver timely feedback.
  • Ensure that all work is performed in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements and assure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
  • Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
  • Champion and actively participate in successful implementation of new products and processes into the facility, including batch record creation, SOP creation, change controls, new equipment procurement, and area changeover activities.
  • Effectively troubleshoot production equipment and processing problems of varying scope with minimal supervision. Raise more complex problems or concerns to senior management for guidance and assistance.
  • Provide continuous development for Manufacturing Associates through activities such as assignments and associated technical training programs. Lead by example, recognize and celebrate successes, and address performance and behavioral issues.
  • Identify problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors and make recommendations for resolution or change to avoid recurrence.
  • Suggest 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.
  • May also perform the tasks and duties of the manufacturing associates.

Qualifications

Education & Experience

Manager

  • High school diploma or equivalent and a minimum of 15 years of related experience in a cGMP and/or bioprocessing environment

OR

  • Bachelor’s Degree in a related discipline and a minimum of 5 years of related experience in a cGMP and/or bioprocessing environment
  • Minimum of 2 years of direct supervisory experience

Senior Manager

  • Bachelor’s Degree in a related discipline and a minimum of 8 years of related experience working in a cGMP environment
  • Minimum of 3 years of direct supervisory experience

 

Knowledge, Skills and Abilities

  • Excellent interpersonal and people management skills with a demonstrated ability to engage, influence, and lead a team
  • Excellent organizational skills and attention to detail
  • Results driven with demonstrated successful outcomes
  • Ability to resolve problems with work processes and people
  • 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
  • Proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)

 

Supervisory Responsibilities

Individual will manage a group of Manufacturing Associates

 

Preferred Qualifications

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

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.