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, GxP Analytical Operations, Gene Therapy

The Manager, GxP Analytical Operations, Gene Therapy position is responsible for oversight of GMP/GCLP analytical operations in Bioanalytics Gene Therapy Laboratories to support conduct of a Phase 1/ 2 clinical trial.  This position will develop GXP-compliant processes and manage a team of analytical scientists to execute standardized workflows. 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 management of GXP analytical operations within the Bioanalytics, Gene Therapy group. This position is responsible for establishing and maintaining GXP-compliant analytical processes suitable for Release Testing and Characterization 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 testing for Gene Therapy Products and patient sample analyses in a phase-appropriate manner in CSL Behring Phase 1/ 2 Gene Therapy Trials.
• Support cGMP/GCLP operations, assay qualification and validation activities Oversee instrument installations and validation, and schedule routine calibrations and preventive maintenance in a timely manner.
• Oversees execution of laboratory experiments and testing both internally and externally with general guidance and Scientific and Technical support from SME.
• Monitor performance of analytical methods through control tracking.
• Conduct lab investigations, manage invalid results, OOS/OOE studies and deviations, implement CAPA and initiate and review change control documentation and other QC investigations.
• Manage Sample Inventory and organize workflows and schedules for the receipt, disbursement, analysis, and archive of test samples.
• Manage Reagents, Laboratory supplies, and Materials Inventory.
• Maintain the lab in a state of inspection readiness.
• Apply problem solving techniques to ensure the Laboratory is regulatory compliant and functioning efficiently to meet Program milestones and deliverables
• Effectively collaborate in cross-functional groups including Cell Manufacturing, Clinical Operations, and Quality Assurance.
• Author Risk Assessments, SOPs and Work Instructions.
• Lead the review of internal SOPs/policies to align with industry standards related to analytical method development and critical reagent life cycle.
• Provide leadership and management support for activities to facilitate training and growth of Scientists to ensure competency and efficiency.
• Implementation of proficiency testing programs in the GxP laboratory.

MINIMUM QUALIFICATIONS/EXPERIENCE

• M.S. or Ph.D. in a Biomedical or Clinical Translational Science discipline.  
• At least 5 years experience managing a regulated (GMP or GCLP) testing laboratory at an Academic Research Institution or Biotechnology company.
• Background in advanced Cell and Gene Therapies is highly desired.
• Experience developing and implementing workflows and procedures for analytical testing, sample management, assay performance tracking, and equipment usage.
• Experience training and managing direct reports.
• Experience authoring SOPs and work instructions and test reports.
• Working knowledge of quality assurance and quality control principles.
• Prior experience working with Quality Assurance and participation in regulatory audits.

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 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

Approachability

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