PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor.
If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!
We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.
We are currently recruiting for an Associate Director of Engineering and Facilities who will report to Senior Director, Manufacturing Operations, and continue advancing PACT Pharma's cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.
We are seeking a seasoned GMP facilities operations management leader with biotech industry or pharmaceutical industry facilities operations and engineering expertise with a solid technical foundation in engineering.
- Provide oversight for facilities, engineering risk management, buildings and properties with direct updates to the executive management team
- Manage and lead capital engineering projects and spend
- Be responsible for IQ/OQ/PQ, commissioning, qualification and validation of GMP facilities and equipment
- Implement and manage CCMS (Computerized maintenance management system), work order system, equipment asset management, and predictive maintenance/reliability engineering
- Meet or exceed customer service and internal department’s KPIs performance
- Ensure effective communication and project plan alignment between business stakeholders, users, Facilities Operations, maintenance, site services, securities, IT, Procurement, Finance, Legal, HR, and all departments regarding all facilities operation’s issues
- Oversee and manage direct reports and third-party service providers to ensure compliance.
- Manage the direct relationship with landlords and/or property Managers, to ensure correct building maintenance and compliance with the agreements signed in the lease contract
- Oversee EHS for the company and ensure compliance
- Ensure compliance with company policy for procurement of facilities services and goods as well as local law and regulations (Building Taxes, Health and Safety)
- BS or MS in Engineering or related field with 8+ years’ experience in GMP facilities expansion and operational management of office space, GMP facilities maintenance, utility systems (water, air, HVAC, etc.), and equipment management
- Proven track record of establishing and managing a robust CCMS (Computerized maintenance management system), work order system, predictive maintenance / reliability engineering
- Expertise in FDA cGMP regulations and requirements for manufacturing-facility utilities that includes understanding of cGMP compliance within controlled space
- Experience managing large capital engineering projects and facilities in a corporate environment
- Experience with a biotech/pharma would be desirable, cell therapy is a plus
- Familiar with the Quality Compliance system is desirable
- Must be able to work on highly complex problems in a variety of situations where analysis is required. Solve problems using considerable and rational judgment, leading to routine and specific recommendations
- Good track record of building and leading high performing team
- Excellent English verbal and written communications skills
- Proven ability to achieve results through positive influence in a matrix environment
- Experience managing budgets and ensure projects stay within budget and timeline
- Experience in the following areas; EH&S, IOP/Q as well as Plant/Equipment commissioning, qualification and validation
PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.