Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations
Company: CSL Limited
Posted on: April 5, 2021
Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations
United States of America R-131187 2012 CSL Behring L.L.C. About CSL
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
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! Job Description
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
- Effectively collaborate in c ross-functional groups, working
with Cell Manufacturing, Clinical Operations, and Quality
- Maintain the lab in a state of inspection readiness.
- Author Quality policies, Risk Assessments, SOPs and Work
- 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
- Oversee instrument installations and validation, and schedule
routine calibrations and preventive maintenance in a timely
- 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
- Manage Samples Inventory and organize workflows and schedules
for the receipt, disbursement, analysis, and archive of test
- 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
- 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
- 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
- Experience implementing and overseeing patient sample
- Experience working on LIMS system is a plus
- Experience participating and/or supporting regulatory
- Experience working in Laboratory environment, handling general
and specialized equipment.
- Overseeing equipment maintenance and calibration, performing
documentation reviews, and escalating any issues
- Advanced knowledge of Safety regulations and FDA guidance.
- Knowledge and good understanding of USP/EP and ICH
- Experience in a Cell/Gene Therapy cGMP/CMC manufacturing and
testing facility is a plus. Core Competencies: 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
Presentation Skills Functional /Technical Skills Technical Learning
CSL VALUES Integrity and Trust Superior Performance Share:
State/Province California Street Address 35 N. Lake Avenue Primary
Location CSL Behring Pasadena Full Time/Part Time Full Time Equal
Opportunity Employer CSL is an Equal Opportunity Employer. If you
are an individual with a disability and need a reasonable
accommodation for any part of the application process, please click
Keywords: CSL Limited, Pasadena , Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations, Executive , Pasadena, California
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