Protein Purification Manufacturing Lead

1 month ago

Rockville, Maryland, United States MacroGenics Full time
Job Summary

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. We are seeking a highly skilled and experienced professional to lead our Protein Purification Manufacturing team. As a key member of our operations team, you will be responsible for planning, executing, and ensuring the success of our manufacturing production operations in the Protein Purification area of cGMP manufacturing.

Key Responsibilities
  • Lead a team of Manufacturing Associates in Protein Purification conducting purification operations including chromatography, filtration, titration, and column packing and unpacking.
  • Ensure staff are adequately trained on all cGMP manufacturing operations and documentation.
  • Ensure that all work is performed in a compliant manner in accordance with site SOPs, EHS standards and cGMP guidelines.
  • Identify and clearly communicate expectations. Schedule and monitor work progress, provide guidance and direction, evaluate results, and deliver timely feedback.
  • Order and account for the consumption of raw materials and components within SAP.
  • Lead the implementation of continuous improvement and operational excellence tools to improve the overall efficiency of manufacturing operations.
  • Create and sustain a highly engaged workforce by providing coaching and professional development opportunities such as specific project assignments and participation in technical and/or professional training programs.
  • 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 without direct supervision. Escalate more complex problems or concerns for guidance and assistance.
  • 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.
  • 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.
Requirements
  • Bachelor's Degree in a related discipline or equivalent experience and a minimum of 7 years of related experience in a cGMP and/or bioprocessing environment.
  • Minimum of 2 years of direct supervisory experience.
Preferred Qualifications
  • Lean Six Sigma / Operational Excellence training.
  • Ability to lead and conduct formal documented risk assessments.
  • Experience writing documents for Regulatory submission (INDs, BLAs, etc.).
About MacroGenics

MacroGenics is proud to be an equal opportunity employer. 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 or call and/or 711 for TTD/TTY service.

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.

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