Careers

Do you want to play a part in the development of cutting edge medicine? Come work with us at XBiotech. We've got some big things we're working on and are looking for smart, talented people to join our team. If that sounds like you, this could be the career path you've been looking for.

The below job openings are in-house at our headquarters in beautiful Austin, Texas. We have great benefits and you'll get the opportunity to work with a biotech company that is pioneering a new era in the discovery and development of antibody therapeutics based on its True Human™ technology. XBiotech is building on a foundation of remarkable new therapies, innovative approaches to commercialization and a commitment to realizing treatments for unmet medical needs worldwide. If interested, able, and available please email your resume to our HR department at careers@xbiotech.com.

VP, ClinOps & Regulatory

Job Responsibilities and Requirements:

  • Serve as high level clinical development strategy lead for both internal and external stakeholders.
  • Provides specific therapeutics area expertise to enhance innovation and efficiency in clinical development.
  • Participates in business development and strategic planning activities to ensure a productive and viable product portfolio.
  • Oversee designing clinical trials and an overall clinical development strategy leading to product registration.
  • Interpret results of Phases 1 - 4 clinical investigations in preparation for NDAs to relevant regulatory authorities.
  • Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents.
  • Prepare, review and provide clinical input to regulatory submissions.
  • Provide clinical development support for Company activities and manage the Clinical Regulatory team and collaborators in the clinical research program.
  • Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed).
  • Establish productive, interactive relationships with key internal departments, including clinical operations, medical, bio-statistics and data management.
  • Help represent the Company as needed as a senior spokesperson to a variety of scientific, business and government groups/agencies.
  • Additional duties and responsibilities that may be assigned from time to time.
  • Develop and oversee clinical sciences operations group including clinical operations, bio-statistics, medical, and data management.
  • Identify need for external support as needed. Oversee vendor selection and management.
  • Oversee program management including identification, management and reporting of program goals, assumptions, activities, schedule, resources, budget, constraints, risks and mitigation strategies and contingency plans.
  • Includes multiple projects or initiatives throughout various life cycle stages.
  • Collaborate with other groups including medical, regulatory, quality and commercial to meet company objectives including development of target product profiles, go/no go criteria, clinical development plans and reporting, regulatory submissions, post marketing studies and publications.
  • Perform due diligence of external opportunities with a focus on clinical and statistical issues.
  • Oversee development of applicable policies and standard operating procedures.
  • Provides required and supplemental training to staff as well as providing ongoing feedback regarding staff performance and assesses performance at least annually.
  • Assures compliance with Good Clinical Practices (GCP) within all Clinical Program Services (CPS) functional areas.
  • Ability to negotiate with clients to assure the company's operational processes are maintained, projects are done within scope, and team members do not initiate in activities based on client request and not best practices.
  • Supports line reports in the management of individual project operational management where escalation is required with appropriate escalation to department heads, colleagues or Executive.

Quality Assurance Associate

General Purpose of Job:

Ensure compliance with company's policies and procedure to meet GMP and regulatory guidelines. High focus on writing, reviewing and editing GMP documentation. Perform in-process inspections and audits of manufacturing activities. Knowledge of FDA and EU guidelines. Focus on writing risk assessments.

Essential Functions:

  • Work closely with manufacturing personnel during routine processing of monoclonal antibodies to ensure key process parameters are achieved.
  • Review manufacturing batch records and SOPs to ensure compliance.
  • Write and revise SOPs following company's document change procedure.
  • Assist with document change control systems.
  • Ensure timely release in-process and finished products.
  • Document and track Corrective Actions/Preventive Actions (CAPA).
  • Assist with QA investigations.
  • Assist with manufacturing and vendor audits.
  • Perform process validations.
  • Perform risk assessments.
  • Perform raw material receiving inspection duties.
  • Work within controlled environment using aseptic technique.
  • Attention to detail and able to interpretation of scientific data.
  • Must have strong trouble-shooting and problem solving skills.
  • Good communication skills (oral and written).
  • Ability to act independently, accept supervision and work quickly and accurately in a fast-paced environment.
  • Fast, efficient, high-level user of MS Word and Excel.

Education/Experience Required:

College degree or BSc, preferably in biological science, with 2+ years hands-on QA experience in a GMP manufacturing environment, preferably bio-pharm.

Education/Experience Preferred:

Knowledge of the regulatory (cGMP, GLP, ICH, CBER, EU GMP Guideline, etc) and technical (production and testing methodologies) work environment preferred.

Physical Demands:

Ability to lift up to 20 lbs. and push 200L barrels while assisting manufacturing personnel.

Work Environment:

Clean room manufacturing environment.


Quality Assurance Validation Specialist

General Purpose of Job:

Provide oversight for all aspects of validation activities for clinical and commercial pharmaceutical manufacturing operations. This will include validation of manufacturing and laboratory equipment, clean utilities (water, process gases, steam, etc), computer systems, and drug substance and drug product process validation. The position will be responsible for validation oversight for the commissioning and start up of a new biotechnology manufacturing facility capable of producing both drug substance and drug product.

Essential Functions:

The ideal candidate will have at least 5 years experience in pharmaceutical validation. Experience must include support of mammalian cell culture drug substance manufacturing facilities, plant start-up and commissioning projects, and knowledge of computer validation (21 CFR Part 11). Preference will be given to candidates who have demonstrated experience operating at both a strategic level (setting up validation systems and risk management plans), and the tactical level (authoring validation documents). Experience working directly with regulatory agencies during inspections is a plus. A working knowledge of lean manufacturing concepts and operational excellence is desired.

Education/Experience Required:

Candidates must have a Bachelor's degree in Engineering, Chemistry, Biology, or other applicable area of Life Sciences.pharm.

Education/Experience Preferred:

Knowledge of the regulatory (cGMP, GLP, ICH, CBER, EU GMP Guideline, etc.) and technical (production and testing methodologies) work environment preferred.


Associate Director Supply Chain

General Purpose of Job:

Provide oversight for all aspects of supply chain function for clinical and commercial manufacturing operations. This will include planning for proper inventory levels of GMP raw materials, product intermediates, and finished goods, ordering and receipt of GMP raw materials, operation of GMP warehouse to include shipping and receiving activities. The position will be responsible for oversight of existing operations as well as development of systems and processes to support commissioning and start up of a new biotechnology manufacturing facility capable of producing both drug substance and drug product.

Essential Functions:

The ideal candidate will have at least 8 years experience in pharmaceutical supply chain operations. Experience must include management of GMP warehouse operations and staff, inventory management systems, and regulatory agency interactions. Preference will be given to candidates who have demonstrated experience operating at both a strategic level (supporting development of GMP compliant systems and processes), and the tactical level (oversight of GMP material receipt, inventory management, cycle counting, etc). Candidates should have a good understanding of current Good Distribution Practices (cGDP), Food and Drug Administration (FDA) and other global regulatory requirements. Experience working directly with regulatory agencies during inspections is a required.

Education/Experience Required:

Candidates must have a Bachelor's degree in Business, Supply Chain Management/Logistic, or other applicable area.

Education/Experience Preferred:

Knowledge of the regulatory (cGMP, GLP, ICH, CBER, EU GMP Guideline, etc) and the bio-pharmaceutical work environment a must.

Management Responsibilities:

Leadership of supply chain associates. Responsible for staff development and mentoring, performance evaluations, and administration of budgets.


Quality Control Research Associate

General Purpose of Job:

Perform QC Routine Testings.

Essential Functions:

  • Perform QC regular testing for Flow-based bioassays and other QC assays as needed.
  • Assist various assay development and validation activities under supervision.
  • Maintain accurate and up-to-date records of results. Report results to management.
  • Assist in writing and/or revising technical documents including assay protocols and reports.
  • Assist in maintaining and testing critical laboratory reagents.

Education/Experience Required:

Bachelor of Science degree from accredited university or college in one of the Biological Sciences

Education/Experience Preferred:

Experience with Flow Cytometry and cell/tissue culture preferred.

Physical Demands:

Ability to lift up to 20 lbs. and push 200L barrels while assisting manufacturing personnel.

Work Environment:

cGMP laboratory


Upstream Production Manager

General Purpose of Job:

Manage upstream production of our clinical and commercial manufacturing operations.

Essential Functions:

  • Oversee the upstream mfg team to meet clinical and commercial demand of our antibody.
  • Plan media production, seed culture initiation, seed culture production, 500L bioreactor prep and production.
  • Coordinate reactor harvest, followed by break down and clean up.
  • Work within controlled environment using aseptic technique.
  • Manage and mentor current and future upstream process team members.
  • Troubleshoot issues regarding deviations and develop a plan for resolution.
  • Attention to detail and able to interpretation of scientific data.
  • Must have strong trouble-shooting and problem solving skills.
  • Good communication skills (oral and written).
  • Ability to act independently, accept supervision and work quickly and accurately in a fast-paced environment.
  • Fast, efficient, high-level user of MS Word and Excel.

Education/Experience Required:

BSc, preferably in biological science, with 5 years hands-on production scale cell culture experience in a GMP manufacturing environment, preferably bio-pharm. Strong background in CHO cell biochemistry/metabolism as well as media development

Education/Experience Preferred:

Previous work with single use bioreactors is a plus, as is previous work in upstream process development.

Physical Demands:

Ability to lift up to 20 lbs. and push 200L barrels while assisting manufacturing personnel.

Work Environment:

Clean room manufacturing environment.


Downstream Production Manager

General Purpose of Job:

Manage downstream production of our clinical and commercial manufacturing operations.

Essential Functions:

  • Oversee the downstream mfg team to meet clinical and commercial demand of our antibody.
  • Coordinate reactor harvests.
  • Oversee all unit operations after reactor harvest prior to fill finish.
  • Work within controlled environment using aseptic technique.
  • Manage and mentor current and future upstream process team members.
  • Troubleshoot issues regarding deviations and develop a plan for resolution.
  • Attention to detail and able to interpretation of scientific data.
  • Must have strong trouble-shooting and problem solving skills.
  • Good communication skills (oral and written).
  • Ability to act independently, accept supervision and work quickly and accurately in a fast-paced environment.
  • Fast, efficient, high-level user of MS Word and Excel.

Education/Experience Required:

BSc, preferably in biological science, with 5 years hands-on production scale chromatography experience in a GMP manufacturing environment, preferably bio-pharm. Strong background in protein purification and UF/DF.

Education/Experience Preferred:

Previous work with single use processing systems a plus, as is previous work in downstream process development.

Physical Demands:

Ability to lift up to 20 lbs. and push 200L barrels while assisting manufacturing personnel.

Work Environment:

Clean room manufacturing environment.


Manager of Clinical & Residual Testing (Austin, TX)

Job Responsibilities and Requirements:

  • Investigate, create, & develop new methods and technologies for project advancement.
  • Research with development of improved protocols for quantitative analysis of in-house produced MaBP1.
  • Design, optimize, research, develop, & quality control Elisas for detecting anti-gen/antibody's concentrations.
  • Validate in-house products with commercially available antibodies for cross reactivity with different types of immunoglobulin.
  • Analyze molecular datasets for basic research purposes.
  • Evaluate, interpret & assess experimental data.
  • Requires Bachelor's degree in Biomedical Engineers or foreign equivalent plus 2 years' relevant work experience.

Mail resumes to Xbiotech USA, Inc. 8201 E. Riverside Dr. Blvd 4, Ste 100, Austin, TX 78744.