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Arbutus Biopharma

Principal Scientist, Analytical Development

Quality – Warminster, Pennsylvania
Department Quality
Employment Type Regular Full-Time
Minimum Experience Experienced

About us:

At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV).  We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape.  We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.

 

If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.

Role Summary:

Reporting to the Sr. Director, Quality, the Principal Scientist, Analytical Development will be responsible for managing analytical method development, technology transfers, and related CMC activities in collaboration with internal/external resources and external testing labs/product manufacturers to advance products in Arbutus’ diverse pipeline in line with corporate and project objectives. 

 

Duties and responsibilities:

•           Manage in-house method development/optimization activities and where appropriate, carry out hands on lab work in support of research and development projects

•           Support in-house pre-formulation and formulation studies

•           Work closely with CROs/CMOs to transfer/establish and validate methods for raw materials, intermediates, API and drug product that meet industry standards and regulatory requirements, providing technical support as needed

•           Propose and conduct product characterization studies and troubleshooting studies in collaboration with internal and external resources, critically evaluate data while drawing appropriate conclusions and develop a forward plan of action

•           Critically review, analyse and trend analytical data generated in-house and by external vendors and apply statistical analyses where appropriate

•           Recommend and justify purchase of analytical equipment to upgrade internal capabilities in support of on-going development programs

•           Write development reports and regulatory submission sections

•           Other responsibilities as assigned

 

Qualifications:

•           PhD in a related discipline, with a minimum of 10 years’ industry experience, or an equivalent combination of education and experience.

•           Progressive experience in the pharmaceutical industry required; experience working in a fast paced biotech environment preferred.

•           A proven track record of problem solving, analytical method development and product characterization.

•           Significant experience with HPLC analysis and method development. 

•           Significant experience with HPLC-MS, including identification of impurities.

•           Knowledge of statistical analysis, including data trending.

•           Experience leading technology transfers to external vendors and on-going management of these external collaborations.

•           Excellent verbal and written communication skills; experience with development report generation and authoring of regulatory submissions.

•           Knowledge of ICH Guidelines and related regulatory guidances, cGMP.

•           Excellent interpersonal and leadership; proven ability to mentor/manage other scientific staff in a matrix environment. 

•           Proven track record of building and maintaining strong relationships with internal and external stakeholders.

•           Ability to manage deadlines and prioritize effectively, while maintaining flexibility.

•           Ability to work independently with minimal supervision, take initiative and take on responsibility for projects.

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  • Location
    Warminster, Pennsylvania
  • Department
    Quality
  • Employment Type
    Regular Full-Time
  • Minimum Experience
    Experienced
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