Scientist, Bioanalytics & Gene Therapy

Employer: CSL Behring
Location: Pasadena, California
Start date: May 12, 2021

Discipline: Science/R&D, Biotechnology, Biotherapeutics, Genetics
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Biotech Beach

Job Details
Company

Job Details

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

Scientist, Bioanalytics & Gene Therapy

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 required.
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 Scientist.

Responsibilities:

Develop 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 cellular and molecular assays. Analytical methods include DNA-, RNA-, cell- and CFU- based assays as well as flow cytometry.
Collating, presenting and analyzing 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 department.
Present experimental data at departmental or project meetings.
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 records maintained.
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
Support staff (central services, validation, engineering etc)
Vendor / Suppliers

Job Environment

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:

A 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 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:

Strong background in lentiviral vector gene therapy with hands-on experience in characterizing lentiviral vectors and gene-modified cell products. Experience in assessing vector potency with DNA- and RNA- based methods is highly desired.
Competence in designing assays and formulating strategies for workup and qualification.
Well-versed in DNA and RNA isolation and characterization (qPCR, ddPCR, multiplex PCR), and recombinant DNA methods. Quantitation of small RNAs including short hairpin RNAs is a plus.
Well-versed in cell culture, HSPC culture, cell enrichment, isolation and culture of human MNCs from peripheral blood and bone marrow.
Experience in multicolor flow cytometry and immunophenotyping.
Well organized, 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 reporting.
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 English.
Scientific report writing and presentation skills.
Mechanical aptitude and problem-solving 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

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.

CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.

CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info

Phone: 610-878-4000
Location: 1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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