Allergan Scientist, Analytical Development in Irvine, California
Scientist, Analytical Development
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/7583/other-jobs-matching/location-only
Dec 24, 2018Post Date
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.
The Scientist position will be based in Irvine, CA. Reporting to the Director, Small Molecule Product Development, the Scientist must have practical breadth and depth of knowledge in a variety of analytical techniques. Independently designs and implements detailed procedures and performs laboratory experiments developing novel methods to solve challenging analytical problems, validates and transfers methods to support all stages of drug development for assigned projects. Demonstrate method suitability for applications to drug substance and drug product development, scale-up and commercialization. Participates in bench-level drug substance/product stability testing and release of test articles and generates and evaluates accurate and precise data using advanced, validated analytical technologies. Provides analytical support for investigative studies and troubleshooting analytical issues. Interacts with contract laboratories for assigned projects to troubleshoot analytical issues and/or address lab incidents and investigations. Provides technical training and coaching to staff members. Has a working knowledge and understanding of global regulatory requirements and expectations for product registration and ICH Stability Guidelines. Designs, directs and conducts stability studies for drug substance and drug product to satisfy global regulatory requirements. Independently authors 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. Able to critically assess and statistically evaluate stability data to establish specifications, drug product expiration dating and label storage claims. Represents department and participates on cross-functional drug development project teams and coordinatesthe efforts within department to ensure timely completion of all required tasks to meet project milestones. Establishes, directs, coordinates and monitors analytical activities at contract labs and/or Allergan commercial sites. This position has responsibility to take action(s) required to carry out their respective job duties.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Main Areas of Responsibilities
Independently designs, and implements analytical development activities to support all stages of drug development for assigned projects. Plans detailed procedures and performs laboratory experiments to develop novel methods to solve challenging analytical problems. Validates, transfers and executes advanced analytical methods under cGMP for stability and release testing. Designs, implements, and conducts detailed laboratory experiments to demonstrate method suitability for application to drug substances and products analyses from early development through commercialization, complying with regulatory requirements to support Allergan product development.Provides analytical support for investigative studies as a lead investigator and troubleshoots analytical issues (i.e., OOS investigations, method issues, etc.). Evaluates and interprets data and draws conclusions. Proactively interact with appropriate scientists of customer departments on complex project issues to arrive at satisfactory resolution of problems and meet project milestones and serves as a technical resource by providing advice, direction and training to scientific associate staff to enhance their work effectiveness in designing and executing special experiments, troubleshooting instrumentation and evaluating data.Collaborates with departmental supervisors/manager to maintain the integrity of the stability testing program, and provides support for verification and correction of data and other entries in the LIMS to insure accurate, consistent and retrievable data. Interacts with contract laboratories for assigned projects to troubleshoot analytical issues and/or address lab incidents and investigations. Reviews, evaluates and archives contract laboratory generated documentation and keeps supervisor informed of data/quality issues.
Has a working knowledge and understanding of global regulatory requirements and expectations for product registration, and ICH Guidelines. Designs, directs and conducts method development, validation, stability studies and other special studies to satisfy global regulatory requirements. Independently authors well-written memos/protocols, technical reports and appropriate portions of CMC sections of INDs, NDAs, MAAs and responses to regulatory questions for use in submission to world-wide government agencies for final market approval. This may include extensive use of computer systems to provide for statistical evaluation and/or visual presentation of test results. Applies appropriate statistical testing and modeling to generate shelf-life calculations, data pooling, etc., per regulatory guidelines.
Represents Analytical Departments on R&D CMC sub-team(s), launch teams, special task forces, etc. Proactively contributes to drug development teams for strategies and problem solving and contributes to team discussions, communicates significant and relevant events, timelines and action items to appropriate departmental members in a timely manner. Supports assigned projects as analytical lead and works with departmental CMC team members to contribute to team strategies; provides high quality and well-interpreted data to and collaborate with other functional areas to solve technical problems and meet project development milestones. Communicates effectively with all scientific disciplines within Allergan. Proactively develop and maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development and provides technical support, investigates and recommends new technology and research opportunities. With supervisor input, manages assigned projects and ensures timely delivery of all deliverables.Establishes, directs, coordinates and monitors analytical activities at contract labs and/or Allergan commercial sites to ensure quality and timeliness of work. Tracks outside costs and ensures forecasts are accurately updated.
Maintains strong working knowledge of ISO/GLP/GMP and safety compliance through internal and external training. Enforces lab cleanliness, safety requirements and adherence to SOPs to ensure successful outcome of internal and regulatory inspection audits. Writes or modifies SOPs to meet requirements of cGMP and/or regulatory requirements. Actively participates in or leads departmental initiatives for continuous improvement of department’s performance metrics and efficiency of laboratory operation. Stays current with the latest analytical chemistry/technology developments and new techniques by reading literature and other sources or attending technical courses or workshops.
The following listed requirements need to be met at a minimum level to be considered for the job:
A minimum 2 years of experience in the development of analytical methods to support drug development, analysis of data and writing of technical protocols, reports, and submission-level documents is required.
Strong ability to apply advanced chemical analysis principles, theories, techniques and concepts to solve assigned problems related to drug development.
Must have a thorough working knowledge of a wide range of analytical methods (i.e. HPLC, GC, spectroscopy, etc.).
Ability to develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems.
Must be proficient using statistical programs for analytical data evaluation. Ability to critically review and evaluate analytical data and make conclusions/recommendations based on data.
Experience with and an understanding of cGMP is necessary. Experience working in a cGMP analytical laboratory is required. Experience with oversight of drug substance and drug product stability studies to support drug development and product registrations is desired
- PhD. and 0-3 years related experience, or Master degree and 5-6 years related experience, or B.S degree and 10 years related experience in the development of analytical methods. Degree should be in Pharmaceutics, Analytical Chemistry, Pharmaceutical Chemistry or Organic Chemistry.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.