Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
This position is responsible for the development, implementation and continuous improvement of safe, compliant and effective facilities and engineering activity in support of our manufacturing operations and other facilities. The scope of the role covers site equipment and facilities maintenance and calibration programs, facility master planning, capital planning & execution and management of the engineering and facilities operating budgets. The individual is responsible for building a team that will deliver the reliable and uninterrupted operation of the manufacturing site, critical equipment, and facility projects, oversee vendor management of other sites, and maintain a balanced / prioritized capital portfolio and continuous improvement activity that will have a direct impact on growth and success.
Leads Manufacturing Facilities and Engineering
- Provides the vision and leadership to build and sustain an exceptional team to operate and maintain the GMP Cell Therapy Manufacturing Facility, including hiring, mentoring and developing staff.
- Leads the implementation of and adherence to all GMP procedures and policies related to Manufacturing operations
- Works with key stakeholders to develop execution plans to increase capacity and throughput of manufacturing operations
- Champions the implementation of new technologies and systems
- Demonstrates outstanding technical acumen, operational understanding and GMP compliance, Building Management and running the Facility and Engineering Department.
- Provides key leadership for interactions with Regulatory agencies and AHJs (e.g., FDA, OSHA, L&I, City of Frederick).
- Oversees relationships with external vendors responsible for the maintenance and operations of lab and office facilities
- Uses strong communication and teamwork skills to build strong relationships with site, network and external stakeholders.
- Ensures all staff maintain appropriate level of training
- Identifies and mitigates risks in facility operations that could negatively impact safety, quality, delivery, cost, or personnel
- Establishes and effectively manages annual operating budgets for all Facility and Engineering activity
Ensures proper execution of activities associated with capital project management including:
- Works collaboratively with the project directors / leads and vendors on all aspects of facility design, construction, qualification and start-up, including development of project scope and user requirements.
- Liaises with local external / governmental stakeholders.
- Manages preliminary engineering / feasibility studies and cost estimates.
- Oversees capital management processes and provision of capital expenditure documentation creation and approval in partnership with finance.
- Implements process standards and project documentation; scoping documents, RFP’s, capital approval requests, budget tracking, scheduling, commissioning, qualification and project handover.
- Manages construction and engineering activities.
- Ensures engineering documentation is prepared and maintained in accordance with all applicable codes and regulations.
Implements, sustains, and improves facility maintenance and calibration programs including:
- Ensures that production facilities are maintained at a high standard, equipment maintenance and calibrations are performed, and validation protocols and reports are reviewed and approved
- Manages facilities and equipment related vendors including: security personnel, pest control, HVAC maintenance, instrumentation and janitorial
- Implements and oversees maintenance management system and building automation system
- Supports business continuity planning & execution activity where required.
- Establishes and delivers maintenance excellence activity to drive customer service, cost and labor efficiency in support of overall operational success.
Provides leadership to site in the development and execution of site safety activity:
- Maintains a safe and healthy work environment for staff and ensures compliance with relevant rules and legislation in those areas.
- Evaluates hazards and performs risk analysis.
- Ensures that staff (including short duration and temporary contracts) are properly informed on hazards and trained to act in consequence.
- Promotes safe practices and behaviors, verifies EHS rules are implemented and respected.
- Reports immediately all incidents and near-misses, participate in investigations and identify preventive measures to prevent similar accidents in the future.
- Acts as Incident Commander during Fire Drills and Business Continuity Events.
- BS/MS in relevant Science or Engineering discipline or equivalent combination of education and experience.
- 10+ years’ experience (including 5+ years in a senior management role) in GMP engineering & operations.
- Background in Protein Biologics or Cell Therapy Manufacturing preferred.
Knowledge, Skills, and Abilities
- Strong knowledge of GMP & environmentally compliant Facility and Engineering operations. (Including national regulatory requirements)
- Strong knowledge of Pharma technologies and infrastructure (HVAC & Utilities, process equipment, automation, maintenance systems, waste water)
- Strong critical thinking and decision making.
- Solid knowledge in the validation of equipment, utilities, and systems.
- Strong experience in the capital planning & project management.
- Experience in building and developing engineering competency, talent and performance to support successful manufacturing operations.
- Experience in Engineering excellence programs – Reliability, Maintenance, Capital Management & Execution, Environmental & Vendor Management.
• Commitment to ethical scientific investigations and rigorous experimental methods.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Sense of urgency in performance of duties.
• Interpersonal skills that promote a collaborative and productive lab environment.
• Effective and efficient written and oral communication skills.
Submit cover letter and resume:
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.