Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds. This newly created role, Bioanalytical Development, Associate Director will report to the Senior Director, Bioanalytical Development and will provide scientific and administrative direction for the development and validation of bioanalytical methodology to support process development, clinical and commercial manufacture, and preclinical and clinical studies of biologic Drug Products.
This position has accountability for technical decision-making. The Associate Director will be a major contributor to the writing of technical development reports as well as regulatory submissions. The Associate Director will work with the Quality, Regulatory and Supply Chain organizations to ensure that our products meet the highest standards for quality and supply. This position reports to the
- 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 organize 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
- This position requires proven abilities and skills in leadership, project management, and working in cross-functional teams.
- Bachelor's or Master's degree in (Analytical) Chemistry or related discipline
- 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 dosage forms (e.g., lyo, liquid, tablets, etc.)
- Experience in managing the method development life cycle from Phase 1 to post-approval
- Demonstrated technical proficiency, creativity, collaboration with others, and independent thought.
- Strong teamwork skills.
- Excellent verbal and written communication skills with the ability to multi-task.
- Demonstrated proficiency in troubleshooting and problem solving and use of experimental designed to elucidate the effects of variables
Cv to firstname.lastname@example.org 01 2302400 www.rftgroup.ie
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