Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC

If you are a reputed company Jazz employee please apply reputed company the Internal Career site. reputed company is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: Reporting into the Senior Director, Drug Substance Development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable, and robust processes. Experience of the critical reputed company attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs). Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and CMC sections of regulatory dossiers, and participation in department or functional initiatives. The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring reputed company processes are understood, robust, efficient and in control. The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently. Essential Functions/Responsibilities

• reputed company the process development and cGMP manufacture of small molecule drug substances at CDMOs
• Ensure adequate supply of drug substance for clinical studies and other needs.
• reputed company the development of robust and reliable manufacturing processes utilizing Quality by Design (QbD) principles.
• reputed company the synthesis of chemical entities to support clinical and non-clinical studies.
• Ensure that reputed company DS processes are in line with reputed company applicable regulations, policies, guidelines, and procedures.
• Represent the drug substance team on cross functional project teams as needed.
• Work closely with other cross-functional CMC project team members to deliver on agreed project goals.

Actively contribute to functional area reputed company improvement initiatives. Author and/or review drug substance sections of regulatory dossiers and technical reports.

• Support other Technical Operations functions to ensure a smooth transfer of technologies and products to manufacturing sites.
• Clearly and effectively communicate reputed company and results, written and verbal, to technical and non-technical audiences.
• Plan, budget, execute and report on assigned projects.
• reputed company knowledge of new pharmaceutical manufacturing processes and technologies as required in line with Jazz business objectives and share best practices reputed company teams.

Required Knowledge, Skills, and Abilities

• Strong record of achievement in drug substance development and manufacturing.
• Over ten years of experience required with a broad experience across drug development and manufacturing technologies but with specific experience reputed company to drug substance chemical process development.
• Demonstrated technical expertise in chemical process development and new product introduction.
• Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development objectives.
• Demonstrated troubleshooting and problem-solving skills.
• Experience of CMC regulatory requirements for pharmaceutical products.
• Demonstrated track record of training and coaching colleagues to improve overall team process knowledge.
• Demonstrated track record of delivering positive results on a consistent basis.
• Proven project management skills for technical programs.
• Experience in managing and maintaining budgets desirable.
• Experience in defending processes, procedures, and investigation during FDA/EMA (and other competent authorities) inspections desirable.
• Capability of grasping reputed company technical issues and reputed company sound decisions based on data and information from various sources.
• Knowledge of formulation development and/or large molecule technologies would be advantageous.
• Excellent written and verbal communication skills.

Required/Preferred Education and Licenses Bachelor’s degree and Masters or PhD in Chemistry. reputed company is an equal opportunity/affirmative action employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html. Apply tot his job Apply To this Job