Associate Director Bio-Analytical Development
This international company focuses on improving patients lives by identifying, developing and commercialising meaningful products that address unmet medical needs. Since their founding they have focused on putting the patient first and this remains their priority as they continue to develop, acquire and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 1000 staff globally with offices in the U.S. and Europe, they are a continually growing company with a broad portfolio and a very healthy pipeline. Due to continued expansion, this organisation are now looking to appoint an Associate Director of BioAnalytical Development to their growing team.
- Manage Analytical method development at CRO and CMOs, including overseeing work flows, progress and milestone achievements.
- Responsible for all aspects of analytical method transfer to designated manufacturing and quality control groups at third party facilities.
- Interface with global manufacturing CMOs to ensure methods being developed represent commercially practical quality and process controls.
- Define appropriate analytical methodology for quality and regulatory controls for drug substance, drug product, and critical intermediates.
- Oversee method scouting, qualification, and validation in accordance with appropriate regulatory requirements (FDA at a minimum, EMA a plus).
- Design and manage appropriate stress and stability studies, and organise analysis and reporting of data.
- Prepare, review and revise SOPs and test methods.
- Write/review method development reports.
- Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
- Provide strategic input and interpretation support for clinical and non-clinical studies (e.g., toxicology and pharmacokinetic studies) as needed.
- At least 5 years of hands-on experience in GMP bioanalytical method development and validation.
- Experience managing contract analytical development for biologics.
- Experience in characterisation of a variety of biologics using both orthogonal and standard QC methodologies.
- Experience with different doseage forms (e.g. lyo, liquid, tablets, etc.).
- Experience in managing the method development life cylce from Phase 1 to post-approval.
- Demonstrated technical proficiency, creativity, collaboration with others, and independent thought.
To learn more apply online or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin South