Careers

SENIOR SCIENTIST, R&D - IMMUNOLOGY AND ANIMAL MODEL

Responsibilities:

Manage animal model and in vivo study projects
Select appropriate supporting assays for preclinical studies for identification and quantification of biological drugs in blood, plasma and other fluid or tissues matrices
Method development, optimization and validation of assays according to current industry standards and regulatory guidelines
Develop new technologies to establish or improve the capability of in vivo studies
Direct laboratory efforts for bioassay, immunoassay, anti-drug antibody assay (including screening, confirmatory and neutralizing assay) development, optimization, validation and analysis support for preclinical studies as required
Mentor and supervise junior scientists

Education/Experience Required:

A Ph. D. degree in life science or a related field
At least 2 years post-doctoral training and relevant experiences animal model establishment and in vivo studies
Extensive knowledge in immunochemistry, bioimaging, and assay development

REQUIREMENTS: The candidate should have experience with animal models. Must have experience planning, developing and validating pre-clinical animal studies. The candidate must demonstrate good verbal communication skills, be able to manage multiple simultaneous project assignments and work well in team environments.

Please indicate position title in subject line and send resume to: rd@xbiotech.com

SENIOR SCIENTIST, R&D - MASS SPECTROMETRY

Responsibilities:

Provide overall leadership for development and application of MS and other analytical methodologies in support of current R&D projects with emphasis on the identification and characterization of novel antibody sequences
Take particular responsibility for the development of methods to perform de novo sequencing of IgG sequences isolated from human plasma
Convey results of analytical studies and participate in project discussions with colleagues within the R&D group
Provide supervision and training to research associates as required
Keep up to date with advances in scientific developments especially in relation to mass spectrometry, and IgG sequence elucidation
Prepare high quality scientific reports or presentation at R&D meetings
Ensure that studies are completed in accordance with project timelines
Other duties as required

Education/Experience Required:

Doctorate (Ph.D.) in Biological science with >3 years academic/industry experience
Excellent knowledge and practical experience in mass spectrometry and its application to the identification and characterization of unknown proteins
Understanding of Immunoglobuling sequence and structure
Candidates must have good knowledge of chromatographic techniques including High Performance Liquid Chromatography (HPLC), Ultrahigh-pressure liquid chromatography (UHPLC)
Very positive interests in keeping up to date with new technologies and developments in analytical sciences
Ability to work well independently or in a team environment
Excellent written and oral communication skills

Please indicate position title in subject line and send resume to: rd@xbiotech.com

RESEARCH ASSOCIATE, R&D - PHAGE DISPLAY GROUP

POSITION DESCRIPTION

A position is available within our R&D phage display group. This research associate will help with library generation, panning, screening, protein expression, and characterization. Experience with bacterial culture, cloning, PCR, ELISA is a must; experience with phage display technologies and cell culture is preferable. As Research Associate, you will work as a team member with other Research Associates under close supervision of Senior Scientist and report directly to him/her. All training concerning handling phages, RNA and DNA preparations and analysis will be provided on-site.

Requirements:

MS in molecular biology / biochemistry / or related discipline with at least 1 year of experience
Experience with PCR, ELISA, and cloning techniques
Ability to learn new techniques
Experience with SPR technology and/or mammalian cell culture is a plus

Please indicate position title in subject line and send resume to: rd@xbiotech.com

QC RESEARCH ASSOCIATE - HPLC

POSITION DESCRIPTION

This position will require performing quality control testing of lot release and stability samples, following approved SOP’s and comply with GMP regulations. Minimum 1-3 years experience performing assays in a cGMP-regulated environment is essential. Must have a hands-on-experience with HPLC. Familiarity with ELISA (Host cell protein and Residual Protein A) assays, SDS Page is a definite plus. Basic computer skills in Microsoft Office are required. Individual must have strong organizational skills and the ability to work both independently and within a team structure.

The QC Associate responsibilities include but are not limited to:

Performance of all assigned quality control testing, which will include but not limited to HPLC, ELISA, and SDS PAGE
Maintenance and operation of QC laboratory equipment in a GMP-compliant manner
Writing and revision of Quality Control SOP’s
Manages test samples, reagents and reference standards used in the laboratory
Performance of data entry and trend analysis and ensures laboratory data integrity and traceability

Requirements:

BSc, preferably in biological science or chemistry, with 1+ years hands-on QC experience in a GMP manufacturing environment, preferably biopharmaceuticals
Strong work ethic. Ability to think and act independently, accept supervision and work quickly and accurately in a fast-paced environment. Ability to critically analyze data and proactively solve problems
Good written and oral communication skills. Ability to author, understand and follow complex written procedures. Solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills
Ability to utilize a variety of analytical instruments such as HPLC, CE, microplate readers, ProteomeLab, Biacore, pH meter, biophotometer
Broad familiarity with techniques in molecular biology, cell biology, microbiology and protein chemistry
Familiarity with cGMP, GLP, ICH guidelines and compendial test methods
Skilled in Microsoft Word and Excel

Please indicate position title in subject line and send resume to: careers@xbiotech.com

CLINICAL SENIOR SCIENTIST

POSITION DESCRIPTION

We are currently seeking a highly motivated Sr. Scientist that to join a team involved in pharmacokinetics and Immunogenicity testing of clinical samples to support XBiotech’s clinical trial activities.

Responsibilities:

Manage a group involved in pharmacokinetics and Immunogenicity testing of clinical samples in compliance with CLIA regulations
Manage development, qualification, validation and implementation of quantitative ELISA immunoassays and immunogenicity assays
Interface with clinical regulatory group for sample tracking and documentation, and act as a technical resource for clinical Regulatory group
Provide continued oversight of quality and reliability of clinical tests. Troubleshoot assays to meet the specification criterion
Train and document training of laboratory department personnel on methods and test systems as needed
Write SOPs, validation protocols, reports and memorandums to support clinical sample testing
Research and investigate new technologies and testing systems for Clinical Trials
Full technical responsibility for interpreting, organizing, executing and coordinating overall project assignments
Independently define scope and critical elements of projects including steps to be taken with time-lines to complete as well as the costs associated with test development, validation, and routine operation
Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations
Consults with supervisor concerning unusual problems and developments
Assist and/or coordinate technical transfer of new procedures to appropriate departments as needed

Requirements:

BS in Biochemistry or Immunology with 10+ years experience or MS in Biochemistry or Immunology with 5+ years experience or PhD in Biochemistry or Immunology with extensive ELISA experience
Advanced level of proficiency in development and validation of ELISA
Proficient in statistical analysis and computer programs such as MS Excel and MS Word
Ability to think independently and resolve complex problems without supervision or guidance
Ability to troubleshoot assay and validation problems with minimal guidance or supervision
Ability to research, design, and implement new test systems and assay procedures
Must have strong analytical and problem solving skills
Ability to work effectively in a work team environment
Knowledge of Current Good Manufacturing Practices (cGMP) and the pharmaceutical industry
Knowledge of Clinical Laboratory Improvements Amendments (CLIA) quality system
Excellent oral and written communication skills

Please indicate position title in subject line and send resume to: careers@xbiotech.com

RESEARCH ASSOCIATE FOR CLINICAL ELISA

POSITION DESCRIPTION

We are currently seeking a highly motivated Research Associate that will work as part of a team that performs patient testing to support XBiotech’s clinical trial activities.

Responsibilities:

Perform ELISA using established protocols and written procedures
Assist in development and optimization of immunoassays
Maintain accurate and up to date records of results
Report results to the supervisor
Assist in writing and/or revising technical documents including assay protocols, and reports
Assist in maintaining and testing of stocks of critical laboratory reagents

Requirements:

Successful candidate will have a Bachelor of Science degree or equivalent in one of the Biological Sciences and 1-2 years of experience in performing ELISA, as well as experience in handling human samples
Must have knowledge of general biology and immunology, and standard types of laboratory equipment such as electrophoresis and immunoassay plate readers
Must be able to successfully multitask and have strong organizational skills with strict attention to detail
Must have strong trouble-shooting and problem solving skills
Must have experience with Microsoft Office applications, and laboratory statistics
Must have the ability to function independently and within a cross-functional team environment, whilst maintaining clear communication with the group
Must have an ability to work quickly and accurately in a demanding, fast paced work environment
Familiarity with therapeutic antibody production process development is a definite asset

Please indicate position title in subject line and send resume to: careers@xbiotech.com

QC RESEARCH ASSOCIATE - GENERAL

POSITION DESCRIPTION

This position will require performing quality control testing of lot release and stability samples, following approved SOP’s and comply with GMP regulations. Cell culture skills and knowledge of cell-based assays is required. Minimum 3 years experience performing assays in a cGMP-regulated environment is essential. Knowledgeable on performing HPLC. Familiarity with ELISA (Host cell protein and Residual Protein A) assays, SDS Page is a definite plus. Basic computer skills in Microsoft Office are required. Individual must have strong organizational skills and the ability to work both independently and within a team structure.

The QC Associate responsibilities include but are not limited to:

Performance of all assigned quality control testing, which will include ELISA, SDS page, purity, and cell-based potency assays
Qualification and validation of cell-based assays
Maintenance and operation of QC laboratory equipment in a GMP-compliant manner
Writing and revision of Quality Control SOP’s
Manages test samples, reagents and reference standards used in the laboratory
Performance of data entry and trend analysis and ensures laboratory data integrity and traceability

Requirements:

BSc, preferably in biological science or chemistry, with 3+ years hands-on QC experience in a GMP manufacturing environment, preferably biopharmaceuticals
Strong work ethic. Ability to think and act independently, accept supervision and work quickly and accurately in a fast-paced environment. Ability to critically analyze data and proactively solve problems
Good written and oral communication skills. Ability to author, understand and follow complex written procedures. Solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills
Ability to utilize a variety of analytical instruments such as HPLC, CE, microplate readers, ProteomeLab, Biacore, pH meter, biophotometer
Broad familiarity with techniques in molecular biology, cell biology, microbiology and protein chemistry
Familiarity with cGMP, GLP, ICH guidelines and compendial test methods
Skilled in Microsoft Word and Excel

Please indicate position title in subject line and send resume to: careers@xbiotech.com

BIOSTATISTICIAN

POSITION DESCRIPTION

XBiotech is seeking a Biostatistician to join our growing clinical regulatory department. The Biostatistician will provide statistical expertise in all clinical development activities and work with the clinical regulatory team members including the medical monitor, clinical study manager, and clinical data manager in design and conduct of clinical trials, as well as the evaluation, interpretation, and reporting of study results and regulatory submissions to the FDA. The Biostatistician will also actively participate in protocol development (study design, sample size justification, and safety/efficacy analysis methods) and develop a statistical analysis plan and programming specifications in preparing a clinical study report (CSR) or publications.

Key duties/responsibilities of Biostatistician:

Provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements
Reviews all project protocols, authors protocol statistical analysis sections, and generates study randomization
Provide statistical input into Case Report Forms (CRF) design for assigned projects, and collaborates with data management in developing, reviewing and testing of the CRFs. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained
Provide statistical and programming input into database design for assigned projects, and works with data management to develop, validate and test the study databases, and validate the accuracy, consistency and integrity of the statistical output displays
Participates in regulatory submissions including CSR, IND safety update/Annual Report, and integrated summaries of safety and efficacy in NDA and BLA
Ensures the quality of data and accuracy of analyses in regulatory submissions or publications
Participate in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical and data management questions/concerns from the meeting participants
Provides support for publication of clinical trial results
Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
Represents XBiotech Biostatistics at FDA meetings. Responsible for statistical input to responses to FDA questions

REQUIREMENTS: Masters in Statistics/Biostatistics with at least 6 years clinical trials experience or Ph.D. with at least 4 years clinical trials experience. Must have a comprehensive understanding of theoretical and applied statistics and experience with statistical software packages such as SAS. Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting; experience in clinical trials through at least one BLA/NDA; Ability to communicate effectively at all levels; Strong team contributor with effective leadership abilities.

Please indicate position title in subject line and send resume to: careers@xbiotech.com

IMMUNOLOGIST

POSITION DESCRIPTION

Preparing and implementing preclinical project plans. Responsible for all data analysis and interpretation from a variety of sources within the group and evaluates impact on research projects. Capable of administering, coordinating or leading a project if required. Responsible for ensuring team and projects meet their milestones. Management of a group of scientists/technologists and their workload. Mentoring direct reports in experiment design and data analysis and interpretation. Supervises and carries out precise experimental work to a consistently high standard to ensure accuracy of the data. Provide leadership and direction for development of immunological techniques for support of R & D programs for biopharmaceutical products. Utilize in-house laboratory capabilities and appropriate extramural resources to address the assay support requirements for Development programs. Use a variety of immunological techniques for pre-clinical evaluation of immunotherapeutic antibody drug product candidates and reagents. Maintains an appropriate level of familiarity with the scientific literature and new technology. Establish new techniques. Manage Laboratory to establish best practices, ensure safe working environment, monitor equipment upkeep, calibration and preventative maintenance, assist with equipment trouble-shooting if required. Ensures that all research findings are documented according to company policies and records of the group are kept up-to-date. Suitably trains and manages personal development of staff in their group. Responsible for making project updates/data presentations at project team and departmental meetings. Prepares monthly technical/summary reports. Contributes to the assessment of new product opportunities for the company within existing direction, and writes and assesses complex project proposals.

Specific roles and responsibilities may include:

Select appropriate supporting assays for preclinical and clinical studies for identification and quantification of biological drugs in blood, plasma and other fluid or tissues matrices
Develop assays for detection of immunological response to the drugs, and further characterization of the nature of the immune response
Method development, optimization and validation of assays according to current industry standards and regulatory guidelines
Provide scientific leadership and expertise in analysis and interpretation of immunogenicity data from preclinical and clinical studies
Serve as in-house expert on questions of immunology and serve as the spokesperson for discussions with regulatory agencies concerning scientific and technical issues
Direct laboratory efforts for bioassay, immunoassay, anti-drug antibody assay (including screening, confirmatory and neutralizing assay) development, optimization, validation and analysis support for preclinical and clinical studies as required
Evaluate and select qualified contract research organizations, consultants, and investigators and interact with them to establish productive and relevant collaborations

Requirements:

Ph. D. in Immunology, Microbiology, Biology or related Life Sciences field with 6-10 years experience in the biotechnology industry, exclusive of academic experience
Extensive experience in assay development, trouble shooting, and validation of cellular and molecular immunological assays for support of pharmaceutical and biopharmaceutical product development
A proven scientific leader with in-depth knowledge of the drug development process is desired
Experience in managing a broad-based team focusing on in vivo and in vitro characterization of biologics safety, immunogenicity and efficacy
Good communication skills are required
Novel technology establishment experience in an immunology group for the preclinical evaluation of antibody products is also desired
Extensive expertise with flow cytometry techniques and data analysis
Experience with software for data/statistical analysis
Ability to coordinate multiple activities in support of defined project objectives, generate work plans, execute upon them and accurately analyze data is required

Please indicate position title in subject line and send resume to: careers@xbiotech.com

DIRECTOR OF BUSINESS DEVELOPMENT

POSITION DESCRIPTION

Manages the identification, evaluation, and development of pharmaceutical and biotechnology prospects for new business opportunities. Develops proposals and term sheets for prospects and manages the day-to-day aspects of closing, including the utilization of legal counsel, and coordination with accounting, finance, human resources and other functional areas. Performs market research, analyzes new market opportunities and pursues new business opportunities. Organizes, tracks, documents and reports on the status of all prospects in the business development pipeline. Participates in the development and execution of a comprehensive marketing strategy, including sales and presentation materials, marketing communications, and industry trade shows and conferences. Also participates in the development of strategic partnerships, joint ventures and alliances, as well as technology and intellectual licensing opportunities, with industry, academia and government agencies.

Education/Experience:

Requires BS, MBA is strongly preferred, with a minimum of 8 years experience in selling, networking, and negotiating contracts with pharmaceutical and biotechnology companies at the executive level, specifically within the drug discovery and development areas. Strong business acumen, organizational and analytical skills are required.

Please indicate position title in subject line and send resume to: careers@xbiotech.com

CLINICAL DATA ASSOCIATE

POSITION DESCRIPTION

XBiotech USA, Inc. is looking for a highly motivated, experienced individual to join our team as a CLINICAL DATA ASSOCIATE. This is a full-time position.

The CLINICAL DATA ASSOCIATE will be responsible for performing start up activities including CRF design, database and edit check specifications, and UAT. Perform database cleaning activities for interim review and final data base lock. The CLINICAL DATA ASSOCIATE will focus on creating document templates for deliverables and define new processes or improvements. Candidate will possess excellent interpersonal, written and verbal communication skills.

Job responsibilities include, but are not limited to the following:

Perform start up activities, including CRF design, defining database specifications, edit check specifications, user acceptance testing, CRF completion guidelines and data management plans
Technical expertise building clinical trials in Electronic Data Capture systems
Create listing specifications and perform regular listing reviews
Create new document templates for deliverables and define new processes or improvements
Vendor selection and management experience
Train study team on data management procedures
Interact with study team to meet project deadlines
Create and review data discrepancies
Perform database cleaning activities for interim review and final database lock
Perform SAE reconciliation
Work with CRAs, medical coding and statistical programmers
Create and maintain DM Trial Master File
Track study metrics
Awareness of applicable regulatory guidelines
Possess excellent interpersonal, written and verbal communication skills
BS in related field

REQUIREMENTS: The successful candidate will have a Bachelor’s degree in a related field with a minimum of 2 years experience leading data management activities. This position is office-based at XBiotech headquarters in Austin, Texas.

Please indicate position title in subject line and send resume to: careers@xbiotech.com

CRA

POSITION DESCRIPTION

The CRA II performs and coordinates all aspects of clinical monitoring and site management. This includes conducting site qualification, site initiation, interim monitoring visits and study close-out visits. The CRA monitors progress of subject enrollment, performs source document verification of electronic Case Report Forms (eCRFs), oversees drug accountability, & manages investigational site to ensure compliance with FDA regulations, ICH/GCP guidelines, & company SOPs. The CRA represents XBiotech and develops and maintains collaborative relationships with investigational sites to troubleshoot and resolve routine study conduct issues and routing data related issues.

The CRA II may participate in the study start up process including development and review of study related tools as well as assist the Clinical Research Manager with planning, writing, distributing and maintaining Clinical study related procedures

Position type: Full-time, office based

Required education: BS/BA or higher degree in a scientific or healthcare field

Area(s) of expertise desired: Oncology, Diabetes, Cardiovascular experience preferred, but not required

Minimum Qualifications:

BS/BA or higher in a scientific or healthcare discipline
At least 2 years experience monitoring phase I-III clinical trials
EDC experience required
Proven flexibility and adaptability
Excellent interpersonal skills
Must possess computer literacy and proficiency in MS office
Must live in the Austin area as this is an office based position
Valid Driver’s License and passport

Please indicate position title in subject line and send resume to: careers@xbiotech.com