Scientist, Bioanalytics, Gene Therapy
Company: CSL Limited
Posted on: April 3, 2021
Scientist, Bioanalytics, Gene Therapy United States of America
R-131121 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
Summary of Role:
- To develop analytical methods for release testing and
characterization of gene therapy lentiviral vectors and cellular
products as well as patient sample analysis.
- To provide analytical support for research and product
development activities including preclinical studies, process
development, and pharm/tox studies.
- To manage multiple workflows concurrently to meet timelines for
(pre)clinical trial study reports.
- To transfer assays internally and externally where
- To maintain laboratory quality systems and records of
analytical results. Reporting Structure:
- Position reports to Senior Manager, Bioanalytics.
- The person holding this position should be capable of assisting
in the supervision and training of a CF Level 4 Associate
- Develop PCR-based molecular and cellular assays to characterize
lentiviral vectors and vector-transduced cells.
- Drafting of analytical test procedures, Standard Operating
Procedures, and data collection forms.
- Performing molecular and cellular assays. Analytical methods
include DNA-, RNA-, cell-, and CFU- based assays.
- Collating, presenting, and analysing experimental data,
including statistical analysis.
- Working independently and as part of a team, perform
experimental work and report results.
- Documenting assay results and reporting to Department head or
to other Product Development functions, as required
- Perform Technical Transfer of methods in and out of
- Present experimental data at departmental or project
- Initiating change controls for documents or procedures, closing
out change controls by training of staff.
- Representing the department on the R&D Safety Committee, or
similar representative role
- Performing routine maintenance on scientific instrumentation,
as required. Liaising with instrument engineers for repair and
maintenance of equipment
- Ensuring critical instruments are calibrated and calibration
- Ensure that high safety standards are taken into account and
adhered to as governed by local, state and federal regulations,
laws and policies as well as CSL's policies and directives Key
Relationships (both internal and external)
- Departmental Heads
- Team leaders
- Research & Development Scientists
- Quality Assurance advisors
- Work will be performed in the Pasadena Laboratory Facility. The
position involves both laboratory and office duties.
- Excellent interaction with other R&D and Quality.
- Working hours, some off-hours work when necessary. POSITION
SPECIFICATION Essential Qualifications/Experience:
- An M.S or Ph.D. in molecular biology, immunology, microbiology,
or a related field
- At least five years biomedical laboratory experience,
preferably within a GXP setting supporting Phase I/2 clinical
- Experience in assay development, phase-appropriate assay
validation, and execution of laboratory SOPs.
- Authorization to work in the United States indefinitely without
restriction or sponsorship
- Strong background in analytical method development for DNA and
RNA detection and quantitation: primer/probe design, multiplex qPCR
and RT-qPCR, PCR optimization and troubleshooting. ddPCR experience
is highly desired. Quantitation of small RNAs including short
hairpin RNAs is a plus.
- Competence in designing assays and formulating strategies for
workup and qualification.
- Well-versed in DNA/RNA isolation and characterization as well
as recombinant DNA methods.
- Well-versed in culture of cell lines and generation of cell
- Hands-on experience with characterizing lentiviral vectors and
gene-modified cell products is highly desired.
- Familiarity with HSPC culture, cell enrichment, isolation and
culture of human MNCs from peripheral blood and bone marrow is a
- Well organised, able to plan work appropriately. Attention to
detail. Mechanical aptitude and problem-solving skills.
- Ability to work effectively in a team
- Competence in assay validation, QC/QA, data analysis and
- Understanding of GLP/GMP regulatory requirements in
pharmaceutical drug development.
- Experience working in a Biosafety Level 2 environment.
- Good working knowledge of Word Processing, Spreadsheets, and
general PC familiarity and usage.
- Outstanding verbal and written communication skills in
- Scientific report writing and presentation skills.
- Mechanical aptitude and problem-solving skills.
- Functional/Technical Skills
- Technical Learning
- Problem Solving
- Priority Setting
- Time Management
- Process Management
- Action Oriented
- Drive for Results
- Presentation Skills
- Interpersonal Savvy
- Supervisor Relationships
- Customer Focus
- Peer Relationships
- Integrity and Trust
- Personal Learning
- Self-Development 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 , Scientist, Bioanalytics, Gene Therapy, Healthcare , Pasadena, California
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