Associate Director, Bio Analytical Development
Category: Manufacturing | Country: Ireland | City: Dublin | Type: Regular, Full Time | Job ID: 4126
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
Primary Objective/ Purpose of Position:
Jazz Pharmaceuticals is seeking an Associate Director of Bio Analytical Development to join our Biologics Product Development team. The Associate Director of Bio Analytical Development will provide scientific and administrative direction for the development and validation of bioanalytical methodology to support manufacture and development as well as preclinical and clinical studies of biologic Drug Products. It will partner with the commercial organization and sites. 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. In addition, this position has responsibility to work as a development interface with commercial sites (e.g. Villa Guardia). This position reports to the Sr. Director, Bioanalytical Development.
- Manage contract and in-house method development. Oversee work flow, progress, and milestone achievements
- 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)
- Interface with Global Manufacturing Supply/CMO to ensure methods being developed represent commercially practical quality and process controls.
- Act as a key development interface to commercial for programs (e.g. Villa Guardia)
- Design and manage appropriate stress and stability studies, and organize analysis and reporting of data
- Ensure practices and procedures in GXP assays data analysis are GXP compliant.
- 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 pharmacokinetics studies), as needed.
- This position requires proven abilities and skills in leadership, project management and working in cross-functional work teams.
- Masters or PhD degree in (Analytical) Chemistry or related discipline
- At least 7 years of hands-on experience in GMP bioanalytical method development and validation
- Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables.
- Excellent interpersonal and collaboration behaviors.
- Experience managing contract analytical development for biologics
- Experience in characterization of a variety of biologics by orthogonal methodologies as well as standard QC methodologies for different dosage forms (lyo, liquid, tablets, etc.)
- Experience in managing method development from Phase 1 to post-approval
- Demonstrates technical proficiency, creativity, collaboration with others, and independent thought.
- Strong teamwork skills.
- Excellent written and verbal communication skills with ability to multi-task.
Jazz Pharmaceuticals is an Equal Opportunity Employer.