Director of Engineering & Facilities at Cellares

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotech, PharmaceuticalIndustries

Requirements

Experienced facilities leader with strong background in cGMP operations within biotech or pharmaceutical industry
Innovative, highly motivated, and driven individual
Self-sufficient and able to work in a fast-paced, mission-driven environment
Ability to interface across company functions (scientists, researchers, engineers)
Prepared to tackle broad challenges as company grows

Responsibilities

Develop and implement facilities policies and practices (SOPs)
Drive planning activities, including direct space allocations, moves, facilities construction, modification, and maintenance
Manage and coordinate equipment calibrations, preventive maintenance, and monitoring of equipment and utilities in non-GMP and GMP areas (including repair, modification, and installation)
Establish a computerized equipment maintenance and calibration program using a modern eQMS platform
Manage a building monitoring program, including sourcing, approving, and implementing an electronic building monitoring system
Support an equipment monitoring system for GMP-related equipment
Manage and coordinate contract cleaning services for GMP facility and office space areas
Responsible for emergency repairs of facility and equipment
Review and approve equipment and facilities-related contracts and vendor qualifications
Manage and lead capital engineering projects (CAPEX)
Manage and coordinate facility pest control program for GMP and non-GMP areas
Oversee Environmental Health and Safety (EHS) activities related to GMP and non-GMP environments, including sourcing contract personnel for chemical and biological waste disposal
Capture, analyze, prioritize, delegate, and communicate immediate, short-term, and long-term maintenance projects
Support and assist with expertise in electrical, plumbing, welding, HVAC, refrigeration systems, and other equipment
Respond to emergencies as appropriate during off-hours, holidays, and weekends
Develop and maintain accurate records of maintenance activities
Monitor and order compressed gases
Oversee and manage third-party service providers
Manage direct relationship with landlords and/or property managers to ensure correct building maintenance and compliance with contractual agreements
Author Request for Proposal (RFP) documents for vendors, provide vendor comparisons, and award qualified vendors
Develop and implement commissioning and qualification procedures
Author, review, and approve documents for departmental SOPs and programs
Generate and execute qualification documents (URS, RA, SAT, FAT, IQ, OQ, PQ, and summary reports) to support GxP requirements
Develop, review, and approve room qualification protocols for static areas
Management, operations, and maintenance of all facilities and supporting systems in compliance with GMP, quality, and EHS standards (office space, cGMP cleanroom suites, QC laboratories, warehouse, utility systems, equipment)
Lead maintenance and calibration program, cleaning program, and capital expansion projects including buildouts

Skills

GMP

cGMP

EHS

HVAC

SOPs

Preventive Maintenance

Equipment Calibration

CAPEX

Facilities Management

Cleanroom Operations

Utilities Management

Cellares

Develops and manufactures cell therapies efficiently

About Cellares

Cellares develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO). Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity and reduces costs and process failures compared to traditional methods. The company serves a range of clients, including pharmaceutical companies, and aims to provide efficient and cost-effective manufacturing services for cell therapies. Cellares stands out by combining development and manufacturing processes under one roof, making it a competitive option in the industry.

South San Francisco, CaliforniaHeadquarters

2019Year Founded

$345.3MTotal Funding

SERIES_CCompany Stage

Industrial & Manufacturing, BiotechnologyIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Stock Options

Risks

Emerging biotech startups threaten Cellares' market share with similar solutions.

Potential regulatory delays could impact scaling of new automated systems like Cell Q.

Supply chain vulnerabilities may disrupt production timelines for Cell Shuttle and Cell Q.

Differentiation

Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.

The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.

Cell Q automates QC processes, addressing bottlenecks in cell therapy quality control.

Upsides

Partnership with Sony enhances precision in cell therapy manufacturing processes.

Strategic partnership with Bristol Myers Squibb provides financial boost and validation.

Ossama Eissa's appointment as COO accelerates global expansion and operational capabilities.

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