The Senior Scientist will lead, manage, and implement analytical activities to support drug development for both drug substance and drug product with focus on oral drug products. The Senior Scientist will independently manage multiple projects and ensure timely delivery of all deliverables.
Main Areas of Responsibilities
Demonstrate method suitability for applications to drug substance and drug product development, scale-up and commercialization.
Provide analytical support for investigative studies and troubleshooting analytical issues.
Interact with contract laboratories to troubleshoot analytical issues and/or address lab incidents and investigations.
Implement technical training and coaching to staff members.
Design and conduct stability studies for drug substance and drug product to satisfy global regulatory requirements.
Author well-written critical technical documentation in the form of technical memos, protocols and reports and appropriate portions of CMC sections of INDs, NDAs, MAAs for use in submissions to world-wide government agencies for final market approval.
Provide oversight of stability studies, and support of analytical investigative studies and troubleshooting analytical issues
Supervise, mentor and direct the work of junior professional staff, as assigned.
Prepare well written critical technical reports on the data generated in support of the qualification/validation of new drug products, processes and analytical methods within prescribed timelines in support of regulatory submissions.
Represent Analytical Development on CMC Project teams as Analytical lead. Contribute to team discussions, and communicates significant and relevant events, timelines and action items to appropriate departmental members in a timely manner.
The following listed requirements need to be met at a minimum level to be considered for the job:
Working knowledge of drug development process and understanding of global regulatory requirements and expectations for product registration and ICH Quality Guidelines.
Proven ability to apply advanced chemical analysis principles, theories, and concepts to solving complex problems associated with drug development is required.
In depth experience in a variety of cGMP laboratory activities and analytical techniques applied to testing of drug substance and different pharmaceutical drug product dosage forms.
Working knowledge of extractable and leachable evaluation, analysis and identification is desired.
Ability to independently develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems.
Strong ability to critically review, evaluate and interpret analytical results (including stability data) and lead investigations to resolve analytical issues is required.
Experience in directing, coordinating and monitoring outsourced analytical activities at contract labs is desired.
Experience in authoring relevant CMC sections of regulatory filings is preferred.
Excellent technical written and oral communications as well as organization skills.
Ph.D. degree and 3-4 years related experience is preferred.
MS degree with 7-8 years or a BS degree with 11+ years in the development of analytical methods to support drug development, analysis of data and writing of technical protocols, reports, and submission level documents will also be considered.
Degree should be in Pharmaceutics, Analytical Chemistry, Pharmaceutical Chemistry or Organic Chemistry.
Internal Number: 182038
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.