Scientist, Assay Development & Analytics, GeneTherapy, Flow Cytometry

Employer
CSL Behring
Location
Pasadena, California
Posted
Apr 08, 2021
Ref
R-132169
Required Education
Doctorate/PHD/MD
Position Type
Full time
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:
  • Provide technical expertise for development of flow cytometry assays that are high in quality, accuracy and repeatability
  • 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 required
  • To maintain laboratory quality systems and records of analytical results


Responsibilities:
  • Design, execute, and troubleshoot Flow cytometry-based procedures and assays
  • Lead development, standardization, and validation of flow cytometry assays
  • Draft analytical test procedures, Standard Operating Procedures, and data collection forms
  • Document, analyze and report experimental data, including statistical analysis at departmental or project meetings
  • Maintain laboratory quality systems and records of analytical results
  • Must possess a good understanding of QA and QC in Flow Cytometry, sample staining and acquisition
  • Work independently and as part of a team, perform experimental work and report results
  • Perform Technical Transfer of methods in and out of department
  • Initiating change controls for documents or procedures, closing out change controls as needed
  • Representing the department on the R&D Safety Committee, or similar representative role
  • Ensuring critical instruments are calibrated and calibration records maintained
  • Performing routine maintenance on scientific instrumentation, as required. Liaising with instrument engineers for repair and maintenance of equipment
  • Exhibit moderate to high level of independence while working on multiple projects including contributing to the launch of new platforms/assays
  • 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
  • Responsible for training new Scientists


Key Relationships (both internal and external)
  • Departmental Heads
  • Team leaders
  • Research & Development Scientists
  • Quality Assurance advisors
  • Support staff (central services, validation, engineering etc)
  • Vendor / Suppliers


Essential Qualifications/Experience:
  • A Ph.D. or MS in molecular biology, immunology, microbiology, or a related field, or BS with commensurate experience
  • At least five years biomedical laboratory experience, preferably within a GXP setting supporting Phase I/2 clinical trials
  • 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
Essential Skills, Knowledge & Attributes:
  • Competence in designing assays and formulating strategies for workup and qualification. Prior successful experience developing validated flow-based assays and SOPs for immune monitoring in clinical trial
  • Experience developing flow cytometry panels for tracking hematopoiesis and immunophenotyping of peripheral blood populations such as platelets, T, B, myeloid and lymphoid subsets
  • Experience developing validated multicolor flow cytometry panels for immunophenotyping, functional assays, e.g. ICS and phospho-flow for monitoring immune response in human subjects
  • Experience with multicolor panel design (+ 15 colors), compensation and unmixing using spectral cytometry, and conventional cytometry
  • Experience with cell sorting
  • Analysis and QC of flow cytometry data using FACSDiva, FCS Express software, MACS Quantify and Flowjo
  • Well-versed in cell culture, HSPC culture, cell enrichment, isolation and culture of human MNCs from peripheral blood and bone marrow
  • Flow-based titration of viral vectors and Flow Virometry
  • Experience with multiple single cell Flow Cytometry technologies /systems e.g. Fortessa X20, MACSQuant, Aurora Spectral Flow cytometer, and CyTof is a plus
  • Imaging and Analysis platforms and high-resolution FISH methodologies is a plus
  • Experience with advanced analytical and bioinformatics tools such as tSNE, FLOWDensity, FLOWSom for analyzing and visualizing biomarker data is highly valued
  • Experience with cellular and molecular assays and analytical methods including DNA-, RNA-cell- and CFU- based assays is a plus
  • Understanding of GLP/GMP regulatory requirements in pharmaceutical drug development
  • Experience working in a Biosafety Level 2 environment
  • Serve as an expert technical resource in flow cytometry to fellow scientists. Ability to work effectively in a cross-functional, multi-disciplinary team environment team
  • Well organised, able to plan work appropriately. Attention to detail. Mechanical aptitude and problem-solving skills
  • Good working knowledge of Word Processing, Spreadsheets, and general PC familiarity and usage
  • Outstanding verbal and written communication skills in English
  • ELN, Scientific report writing and presentation skills


Competencies:

As per Lominger competency model;
  • Functional/Technical Skills
  • Technical Learning
  • Problem Solving
  • Priority Setting
  • Organizing
  • Time Management
  • Informing
  • Process Management
  • Action Oriented
  • Perseverance
  • Drive for Results
  • Presentation Skills
  • Written Communications
  • Approachability
  • Interpersonal Savvy
  • Supervisor Relationships
  • Customer Focus
  • Peer Relationships
  • Integrity and Trust
  • Listening
  • Personal Learning
  • Self development