Director, cGMP Manufacturing in Emeryville, California at ZYLIDAC BIO LLC

Zylidac Bio LLC is seeking a Director of cGMP Manufacturing. This position is a senior leadership role responsible for end-to-end execution of biologics drug substance manufacturing operations within a Contract Development and Manufacturing Organization (CDMO). This role oversees buffer preparation, media preparation, upstream and downstream drug substance manufacturing, and manufacturing support functions, ensuring full compliance with US FDA and global cGMP regulations while working with Site Head and leadership to support drug product, packaging and Labeling operations. The candidate must have demonstrated hands-on leadership and subject matter expert experience in leading an end-to-end biologics manufacturing operation.

The Director provides strategic, technical, and people leadership to deliver safe, compliant, high-quality manufacturing operations that meet client commitments, regulatory requirements, and business objectives. This position plays a critical role in scaling operations, supporting technology transfer, regulatory inspections, and continuous improvement initiatives in cell culture, clarification, purification and formulation of drug substances.

This role will also ensure integrated support for Drug Product Filling, Visual Inspection, and Labeling/Packaging operations, including scheduling, staff qualification, execution oversight, and inspection readiness.

The Director will direct, coordinate, and collaborate extensively with cross-functional teams, including Process Development, Quality Assurance, Quality Control, Supply Chain, Facilities, Procurement, and external partners, to ensure seamless execution from process development through GMP manufacturing. The position is responsible for assessing, drafting, approving, and governing GMP quality systems, including change control, deviations, CAPAs, and critical work orders, and serving as a key stakeholder during internal audits, customer audits, and regulatory inspections.

This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.

Zylidac Bio LLC is a leading Contract Development and Manufacturing Organization specializing in the development and manufacturing of biologics, particularly antibodies. We are committed to delivering high-quality products and services that meet the evolving needs of our clients in the biopharmaceutical industry.

cGMP Manufacturing Operations

• Provide overall leadership for biologics drug substance manufacturing, including:
• Media preparation
• o Buffer preparation
• o Upstream processing (cell culture, bioreactors)
• o Downstream processing (chromatography, filtration, concentration)
• Ensure execution of manufacturing campaigns in accordance with cGMP, safety, quality, and schedule requirements
• Drive production readiness, campaign planning, capacity utilization, and resource allocation
• Partner with MSAT, Quality, Engineering, Supply Chain, and Client Services to ensure seamless execution of manufacturing programs

Buffer and Media Preparation

• Oversee media and buffer preparation operations, including:
• o Single-use and stainless-steel systems
• o Raw material staging, dispensing, and preparation
• o Hold time management and lifecycle oversight
• Ensure procedures, batch records, and controls meet regulatory expectations and internal standards
• Optimize buffer and media processes for efficiency, scalability, and right-first-time execution

Manufacturing Support Functions

• Lead and develop manufacturing support teams, including:
• o Manufacturing associates and supervisors
• o Logistics within manufacturing
• o Equipment preparation and changeover
• o Cleaning, sanitization, and environmental controls
• Ensure adequate support coverage for multi-shift operations, including nights and weekends as required
• Implement standardized workflows and visual management to improve execution consistency

Leadership and People Management

• Build, coach, and retain high-performing manufacturing and support teams
• Establish clear performance expectations and development plans for managers and staff
• Promote a culture of safety, quality, accountability, and continuous improvement
• Lead through change, including facility expansion, new technology introduction, and organizational growth

Quality and Compliance

• Ensure full compliance with 21 CFR Parts 210/211, 600s, ICH, and global regulatory requirements
• Serve as a key manufacturing leader during:
• o FDA and international regulatory inspections
• o Client audits and quality assessments
• Own deviation investigations, CAPAs, and risk assessments related to manufacturing
• Partner closely with Quality to ensure strong batch release performance and inspection readiness

Technology Transfer and Client Interface

• Support and lead technology transfer activities from development into cGMP manufacturing
• Collaborate with MSAT and Process Development to ensure robust process understanding and control
• Serve as manufacturing subject matter expert for client communications related to execution, risk, and scheduling
• Drive successful execution of multiple client programs in parallel within a CDMO environment

Continuous Improvement and Operational Excellence

• Implement and champion Lean manufacturing, Six Sigma, and operational excellence initiatives
• Identify opportunities to improve safety, quality, throughput, and cost
• Use metrics and KPIs to drive performance and decision-making
• Support digitalization and data integrity initiatives across manufacturing operations

Required Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biology, or related scientific discipline (Master’s degree preferred)
• 10+ years of progressive experience in biologics cGMP manufacturing
• 5+ years of people leadership experience managing managers and technical teams
• Demonstrated experience overseeing:
• o Buffer and media preparation
• o Upstream and downstream biologics manufacturing
• o Manufacturing support operations
• · Strong working knowledge of FDA and global cGMP regulations

Preferred Qualifications

• Prior experience in a CDMO or multi-client manufacturing environment
• Experience with monoclonal antibodies, recombinant proteins, or other biologics platforms
• Direct participation in FDA or EMA inspections with successful outcomes
• Experience scaling operations or supporting new facility startups
• Familiarity with single-use technologies and modern biologics manufacturing platforms

Key Competencies

• Strategic leadership and operational execution
• Regulatory and quality mindset
• Strong cross-functional collaboration
• Client-focused communication
• Data-driven decision making
• Change management and team development

WORK ENVIRONMENT:

This is an office-based position, located in our office in Emeryville, CA. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is:

• Frequently required to sit and/or stand, walk, talk, and hear.
• Ability to sit at a computer for an extended period of time.
• Vision ability requirements include clarity of visions at 20 inches or less due to computer work.
• Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).
• Constantly required to use hands and fingers to operate office machines and equipment.
• Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.
• On-site presence required in a cGMP manufacturing facility.
• Ability to support off-shift or weekend operations as needed.
• Ability to work in classified manufacturing areas and comply with gowning and PPE requirements.
• The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job.