Director, Quality Control Analytical Sciences and Technology

Description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

Provides scientific and strategic leadership for analytical method lifecycle management within Quality Control. Accountable for ensuring analytical methods remain fit-for-purpose throughout their operational lifecycle through data-driven performance monitoring, investigation of method-related quality events, statistical trending, continuous improvement, and governance of analytical control strategies.

Serves as the primary escalation point for complex OOS/OOT investigations, recurring invalid assays, adverse trends, and emerging method performance risks.

Key Responsibilities:

Analytical Method Lifecycle Governance

• Provide strategic oversight of all GMP analytical methods throughout their operational lifecycle to ensure methods remain fit-for-purpose, compliant, and aligned with product and business needs.
• Establish method ownership, lifecycle review processes, and performance governance.
• Lead scientific assessment and approval of method changes, revisions, requalifications, and retirement activities.
• Drive continuous improvement initiatives to enhance method robustness, reliability, and operational efficiency.

Investigation and Scientific Problem Resolution

• Serve as the highest-level scientific authority for analytical quality events and complex laboratory investigations.
• Provide oversight and approval of significant OOS, OOT, deviation, atypical result, and recurring invalid assay investigations.
• Lead root cause analyses involving methods, instrumentation, reagents, standards, training, and laboratory systems.
• Identify systemic issues and implement sustainable corrective and preventive actions across the QC organization.

Analytical Performance Monitoring and Data Analytics

• Establish a proactive analytical monitoring program that uses data and statistical tools to ensure continued assay control and detect emerging risks.
• Oversee control chart trending and monitoring of critical assay performance attributes, system suitability metrics, and laboratory performance indicators.
• Evaluate trends, shifts, and recurring events to identify opportunities for risk mitigation and process improvement.
• Develop and communicate analytical health metrics, dashboards, and periodic management reviews to QC leadership.

Organizational Leadership and Cross-Functional Partnership

• Build and lead a high-performing scientific organization that provides advanced technical support to QC Operations and the broader business.
• Lead, develop, and prioritize the work of the AS&T team while ensuring appropriate resource allocation and succession planning.
• Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on analytical strategy and issue resolution.
• Serve as the analytical SME during inspections, audits, client interactions, regulatory submissions, and strategic business initiatives.
• Directs activities of functional areas through direct reports. Represents Quality Control in interdepartmental meetings.
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings

Minimum Qualifications:

• B.S. in Chemistry, Biochemistry, or Biology or related field with a minimum of 10 years of industry experience in a QC or analytical laboratory. MS or higher degree preferred.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
• Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $163,000 - $204,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.