Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Manager, Bioanalytics , Gene Therapy, GxP Laboratory Operations

The Manager position is responsible for development, implementation, and oversight of GMP/GCLP Policies and Procedures in the Bioanalytics Gene Therapy Laboratories to ensure Quality Systems operations and regulatory compliance required for conduct of a Phase 1/ 2 clinical trial.  This position is responsible for ensuring that Quality Assurance Systems are fully implemented and Quality Control Procedures and Practices are standardized and successfully executed. This is a highly visible and dynamic position requiring strong leadership and facilitation skills to balance multiple priorities in a highly matrix/team-based organization.

JOB SUMMARY

The successful candidate will be responsible for building Bioanalytics Quality Systems and accreditation capabilities, management and oversight of Quality Control and Operations within the Bioanalytics, Gene Therapy group. This position is responsible for establishing and maintaining GXP-compliant analytical processes suitable for Release and Characterization Assays of Cell and Gene Therapy products as well as patient sample analysis.

This position serves as Bioanalytics Department’s point person in collaboration with Quality Assurance to ensure adherence to GMP/GCLP and company policies, facilitating the implementation and review of QA Policies, SOPs, and Lab Management Systems.  This position will coordinate with Lab Management to ensure laboratory operations, including equipment qualification and maintenance, inventory, as well as shipping and receiving. The position will coordinate with Analytical Development to qualify and validate assays for GXP purposes. The ability to effectively establish and effectively execute procedures, manage staff, and build risk mitigation strategies into GXP analytical operations is essential.

RESPONSIBILITIES     

• Manage a growing GxP Testing laboratory with oversight of Release and Characterization assays for Gene Therapy Products and patient sample analyses in a phase-appropriate manner in CSL Behring Phase 1/ 2 Gene Therapy Trials.
• Champion a highly collaborative, transparent, data driven, 'make it happen', culture.
• Provide leadership and management support for activities to facilitate training and growth of Scientists to ensure competency and efficiency.
• Effectively collaborate in cross-functional groups, working with Cell Manufacturing, Clinical Operations, and Quality Assurance.
• Maintain the lab in a state of inspection readiness.
• Author Quality policies, Risk Assessments, SOPs and Work Instructions
• Ensure that product quality is maintained through execution of a quality control program within laboratory procedures.
• Lead the review of internal SOPs/policies to align with industry standards related to analytical method development and critical reagent life cycle.
• Conduct lab investigations, manage OOS/OOE studies and deviations, implement CAPA and initiate and review change control documentation and other QC investigations.
• Manage Reagents, Laboratory supplies, and Materials Inventory.
• Oversee instrument installations and validation, and schedule routine calibrations and preventive maintenance in a timely manner.
• Monitor analytical method performance through proficiency testing programs, routine assessment of analytical method system suitability requirements, and invalid assay trending.
• Support cGMP/GCLP operations, assay qualification and validation activities.
• Manage Samples Inventory and organize workflows and schedules for the receipt, disbursement, analysis, and archive of test samples.
• Oversees execution of laboratory experiments and testing both internally and externally with general guidance and Scientific and Technical support from SME.
• Apply problem solving techniques to ensure the Laboratory is regulatory compliant and functioning efficiently to meet Program milestones and deliverables.

MINIMUM QUALIFICATIONS/EXPERIENCE

• Advanced degree, M.S. or Ph.D preferred in a Biomedical or Clinical Translational Science discipline, with advanced training and certification in Laboratory Quality Systems and Operations Management.  
• At least five years experience as Laboratory Manager in an Academic Research Institution or Biotechnology company developing policies and procedures for a GMP/GCLP/GxP Testing Laboratory, Advanced Cell and Molecular Therapies, is preferred.
• Ten years of Teams Management experience managing direct reports in a GxP environment and Quality Control Laboratory.
• Experience authoring policy documents, SOPs, protocols and reports for qualification, maintenance, and monitoring of quality control critical reagents and reference standards.
• Experience in working with Quality Assurance for Internal and External Regulatory Audits.
• Experience with statistical analyses for evaluation and monitoring of method performance and Quality Control, e.g. Westgard rules and implementation of proficiency testing programs in the GxP laboratory.

ESSENTIAL SKILLS, KNOWLEDGE& ATTRIBUTES

• Self-driven, independently motivated, data driven and excellent problem-solving ability.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
• Strong critical thinking and decision-making abilities required.
• Strong communication skills, team player, proven negotiation skills.
• Experience implementing and overseeing patient sample management programs.
• Experience working on LIMS system is a plus
• Experience participating and/or supporting regulatory inspections.
• Experience working in Laboratory environment, handling general and specialized equipment.
• Overseeing equipment maintenance and calibration, performing documentation reviews, and escalating any issues appropriately.
• Advanced knowledge of Safety regulations and FDA guidance.
• Knowledge and good understanding of USP/EP and ICH standards.
• Experience in a Cell/Gene Therapy cGMP/CMC manufacturing and testing facility is a plus.

OPERATIONS

Process Management

Planning and Organizing

Time Management

Priority setting

INTERPERSONAL

Peer Relationships

Approach-ability

Motivation

Self-Development

Customer Focus

ENERGY AND DRIVE

Personal Learning

Action Oriented

Drive for Results

Perseverance

ORGANIZATIONAL

Written Communications

Presentation Skills

Functional /Technical Skills

Intellectual Horsepower

Technical Learning

CSL VALUES

Patient Focus

Innovation

Integrity and Trust

Collaboration

Superior Performance