Homology is searching for a GMP Facilities Lead to be a member of our Manufacturing Operations team. The person will be responsible for GMP Facilities design, construction, and start-up of a new Phase I/II cGMP manufacturing facility. The role will recruit, manage and develop the GMP Facilities team to support daily operations of the cGMP manufacturing facility. This person will also need to partner with multiple functions to ensure appropriate systems are in place needed to support cGMP operations including metrology and maintenance 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 utilities of a GMP manufacturing facility.
Essential Functions and Duties
- Support the design, construction, and commissioning of a new cGMP Manufacturing facility focused on clean utilities
- Recruit, manage, and develop a team to run daily facilities operations
- Develop appropriate programs and systems related to maintenance and operations of GMP equipment and utilities
- Partner with Manufacturing and Engineering to ensure appropriate maintenance intervals and rigor
- Develop and manage of budget related to Facilities operations
- Partner in creation and execution of facilities systems in support of GMP operations
Skills and Experience
- Experience in start-up and operation of GMP clean utilities and manufacturing facilities support
- Bachelor’s degree level education or equivalent years of experience
- Minimum 8 years of experience in operation of clean utilities and facilities operations within a biotech/pharmaceutical environment.
- Hands-on expertise with utilities design, facility design, engineering 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 firstname.lastname@example.org.