GMP Manufacturing Lead

Homology is searching for a GMP Manufacturing Lead to be a member of our Manufacturing Operations team. The person will be responsible for start-up of a new Phase I/II cGMP manufacturing facility. The role will recruit, manage and develop the GMP manufacturing team to support daily manufacturing operations. This person will work cross-functionally to ensure appropriate systems are in place needed to support cGMP operations including technician qualification and training programs.

The person will be a part of a team to advance a fundamentally important aspect of the Company’s long-term success focused on internal manufacturing capability. The ideal candidate is creative, team-oriented and has hands-on experience in all aspects of start-up and operation related to GMP manufacturing.

Essential Functions and Duties

  • Perform initial start-up and shakedown of facility and process equipment
  • Partner with QA and Engineering to develop and execute QVC activities
  • Recruit, hire and train manufacturing staff members
  • Partner with Process Development to define and scale-up manufacturing unit operations
  • Assist with the development of manufacturing programs such as training
  • Deploy manufacturing documentation including SOP’s and Batch Records
  • Plan, prepare, and oversee end-to-end manufacturing operations
  • Schedule plant activities including manufacturing, maintenance and changeover
  • Track, trend and communicate manufacturing run data
  • Lead, motivate and develop manufacturing technicians and supervisors
  • Author process deviations and investigations as necessary
  • Drive the initiation, management and closure of change initiatives
  • Provide technical expertise to management and less experienced professionals
  • Assist with fostering partnerships with external stakeholders

Skills and Experience

  • Experience in start-up and operation of GMP manufacturing facility and equipment
  • Minimum of 8 years of experience in GMP pharmaceutical/biologics manufacturing
  • Bachelor’s degree level education or equivalent years’ experience
  • Direct experience leading manufacturing teams
  • Experience with Tech Transfer from Development to Manufacturing is preferred
  • Direct experience with biologics Drug Substance required, Drug Product experience preferred
  • Strong background in facility operation and design, commissioning, and validation is preferred
  • Excellent communication, technical, organizational, and interpersonal skills are essential
  • Flexibility to accommodate to rapidly changing priorities and deadlines
  • Must be a team player prepared to lead, work in, and embrace a team-based culture

Interested candidates should forward a cover letter and resume/CV to