PasadenaCARecruiter Since 2001
the smart solution for Pasadena jobs

Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations

Company: CSL Limited
Location: Pasadena
Posted on: April 5, 2021

Job Description:

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 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! 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 and efficiency.
  • Effectively collaborate in c ross-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.
      • 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. 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 below.

Keywords: CSL Limited, Pasadena , Manager, Bioanalytics, Gene Therapy, GxP Laboratory Operations, Executive , Pasadena, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Assistant Property Manager
Description: StorAmerica Management - Looking for Energetic Self Storage Agents br br No experience No problem We provide a comprehensive 3 week training program, guaranteeing your success br br Pay range: (more...)
Location: Perris
Posted on: 04/15/2021

CMT Project Manager
Description: Braun Intertec is seeking a CMT Project Manager to join our Beaumont, TX, office.-- Responsibilities: ul li Writes basic reports giving professional opinions and recommendations applying standard (more...)
Company: Braun Intertec Corporation
Location: Beaumont
Posted on: 04/15/2021

Human Resources Assistant Manager
Description: Executive Team Leader Human Resources Job Description ALL ABOUT TARGET As part of our collaborative and guest-obsessed team, you help us create an experience that makes guests say, I love Target When (more...)
Company: Target
Location: San Gabriel
Posted on: 04/15/2021

Electrical Engineer Project Manager (Public Works, Water & Wastewater) _ Los Angeles, CA
Description: Job Title: Electrical Engineer Project Manager Industry: Electrical Engineering Consulting Power Lighting Distribution Office Location: Los Angeles, CA 91748 We are looking for experienced, accomplished, (more...)
Company: TJG Civil Engineers and Land Planners
Location: Rowland Heights
Posted on: 04/15/2021

Vice President, Financial Consultant - Monterey, CA
Description: Job Description:Fidelity Investments Racial Equity Diversity Pledge Fidelity believes in, and is committed to, fair and consistent treatment for every associate and customer, and to creating a safe (more...)
Company: Fidelity Investments
Location: Monterey Park
Posted on: 04/15/2021

Senior Project Manager - Engineer - Poway, CA
Description: Responsibilities: ul li Develop and lead multiple concurrent regional improvement projects supporting business strategy including facility rationalization and growth initiatives. li Ownership
Company: Peterson Construction
Location: Poway
Posted on: 04/15/2021

11B Infantryman - Management Training - Ground Forces
Description: The Infantry is the backbone of the Army. These Soldiers fill the literal boots on the ground who are responsible for taking or holding ground during any combat operation. You'll attack, repel, and capture (more...)
Company: Army National Guard
Location: Apple Valley
Posted on: 04/15/2021

Shop Manager Jobs: Hiring Immediately! Full Time / Part Time - $12-$22/Hr
Description: Find your next job here Will
Company: Retail Jobs
Location: Glendora
Posted on: 04/15/2021

Property Management
Description: We are looking for an efficient Property Manager to manage the daily operations of properties, advertise vacant properties, and handle tenant relations. The Property Manager's responsibilities include
Company: PeopleReady
Location: Redlands
Posted on: 04/15/2021

In House Counsel Jobs - JDHuntr 39543 Senior Director, Business, San Diego, CA
Description: In House Counsel Jobs - JDHuntr 39543 Senior Director, Business, San Diego, CA To apply go to responsible for leading and
Company: JDHuntr In-House Counsel Jobs
Location: Encinitas
Posted on: 04/15/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Pasadena RSS job feeds