Based in the Pacific Northwest and with research facilities in the North East, our client is an established, clinical phase biotechnology company with a broad portfolio of drug candidates, a commercial delivery platform and other novel therapies in the pipeline. They are advanced in achieving their vision to provide a cure to transform the Hepatitis B virus (HBV) treatment landscape.
About the Role:
The Senior Manager Analytical CMC will be responsible for managing analytical technology transfers, method development and related CMC activities in collaboration with internal resources and external testing labs/product manufacturers to advance products in a diverse pipeline in line with corporate and project objectives.
Duties and responsibilities:
- Work closely with CROs/CMOs to transfer/establish and validate methods for raw materials, intermediates, API and finished products that meet industry standards and regulatory requirements, providing technical support as needed;
- Manage stability studies and critically review, analyse and trend analytical data generated in-house and by external vendors and apply statistical analyses where appropriate;
- Write development reports and regulatory submission sections;
- Propose and conduct product characterization studies in collaboration with internal and external resources, critically evaluate data while drawing appropriate conclusions and develop a forward plan of action;
- Foster a spirit of cooperation, teamwork and motivation within the department;
- Masters or 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 bio-pharmaceutical industry required and ideally experience working in a fast-paced biotech environment.
- A proven track record of problem solving, analytical method development and product characterization.
- Experience with HPLC analysis required.
- Knowledge of statistical analysis, including data trending.
- Knowledge of analytical methods used to characterize lipids and/or oligonucleotides is an asset.
- Experience with technology transfers to external vendors and on-going management of these external collaborations is an asset.
- Knowledge of ICH Guidelines and related regulatory guidance, cGMP.
- 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.
- Exceptional verbal and written communication skills with experience in report generation and authoring of regulatory submissions.
For more information, please contact Tim Swanson at email@example.com or +1-604-639-9566